April 15, 2024
In the context of clinical trials, reducing the workload of the clinical team without compromising data quality is...
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April 12, 2024
How should health technology developers prepare for future market access activities in Europe? Numerous discussions...
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April 10, 2024
Orphan drug designation is a regulatory status granted to pharmaceuticals developed for the treatment of rare diseases....
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April 8, 2024
In this latest edition of the Career Perspectives series, we are excited to introduce our readers to Joshua Murray,...
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April 5, 2024
Written by Sydney Ringold, Customer Success Manager, and Kevin Trimm, Chief Product Officer In an ever-changing...
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April 3, 2024
Thank you to Charlotta Gauffin, Chief Scientific Officer at Dicot, for joining us for our recent webinar, “The Road to...
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April 2, 2024
Data monitoring committees (DMCs) review ongoing clinical trial data to make recommendations regarding trial conduct...
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March 20, 2024
Written by Lydia Vinals, PhD, and Grammati Sarri, PhD The draft Implementing Act of the EU Health Technology Assessment...
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March 13, 2024
Group sequential clinical trial designs — a type of adaptive clinical trial design — have emerged as a powerful tool in...
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March 11, 2024
In 2023, rare diseases accounted for 30% of product pipeline under development, about half of which comprising...
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March 4, 2024
In this new installment of the Career Perspectives series, we had the privilege of interviewing Arnold van Aswegen,...
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February 26, 2024
Written by Boaz N. Adler, MPA, Director, Global Product Engagement, and Valeria Mazzanti, MPH, Associate Director,...
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February 20, 2024
In clinical trials based on count data, the aim is to compare independent treatment groups in terms of the rate of...
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February 14, 2024
During drug development, a comprehensive regulatory strategy is key for saving time and money. There are many common...
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February 13, 2024
Written by Boaz N. Adler, MPA, Director, Global Product Engagement, and Valeria Mazzanti, MPH, Associate Director,...
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February 2, 2024
When building a disease model or an economic model, the assumption has been that updates to such models should only...
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January 26, 2024
Innovations in the process of designing adaptive clinical trials have unlocked new possibilities for designing and...
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January 22, 2024
Regulatory guidelines outline all crucial studies and documentation that should be in place before a drug product can...
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January 19, 2024
Independent data monitoring committees help to ensure patient safety and uphold trial integrity. In Central Nervous...
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January 17, 2024
Despite accumulating learnings from early phases, several uncertainties remain to be addressed when designing pivotal...
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January 15, 2024
After explosive and frenetic activity in the clinical trial industry during the COVID era, the past two years have seen...
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January 10, 2024
A clinical development strategy is a comprehensive plan designed to establish the safety and efficacy of new...
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January 3, 2024
Ten years ago this month, in January 2014, the FDA issued the first version of its Technical Conformance Guide (by...
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December 29, 2023
What a year! Perspectives has explored a myriad of topics this year within clinical development — from adaptive trial...
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December 27, 2023
Perspectives covers a wide range of topics related to data submission and data integration, from ISS and ISE best...
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December 22, 2023
Perspectives covers a wide range of topics within therapeutics development from advice on regulatory submission to...
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December 20, 2023
Perspectives covers a wide range of topics related to real-world evidence and real-world data, from overcoming health...
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December 15, 2023
In clinical trials, high-quality data is essential. It drives the drug development decision-making process and is a...
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December 8, 2023
Regular technical discussions with the FDA play a critical role in ensuring data submission success. These discussions...
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December 6, 2023
Chemistry, Manufacturing, and Controls (CMC) is a critical component of drug product development. As a Senior...
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December 4, 2023
Independent data monitoring committees review unblinded clinical trial data and issue recommendations to designated...
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December 1, 2023
Last week, Robert Szulkin, Research Principal, Real World Evidence, discussed the need for real-world evidence studies,...
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November 29, 2023
A clinical trial is usually performed using some kind of comparator. This could be another drug on the market, or a...
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November 24, 2023
Regulatory requirements regarding documentation for new medicines are constantly evolving. Previously, randomized...
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November 20, 2023
Interpreting all guidelines before your first-in-human clinical trials can be overwhelming. While guidelines are...
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November 17, 2023
Cytel’s Functional Service Provision (FSP) teams work on exciting projects with biotech and pharmaceutical companies as...
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November 13, 2023
For nonclinical studies that precede Phase I, a drug formulation in high doses and concentrations is required. While...
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November 10, 2023
Independent data monitoring committees review unblinded clinical trial data and issue recommendations to designated...
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November 8, 2023
Written by Natalia Muehlemann, Vice President, Clinical Development, and Ari Brettman, Senior Managing Director,...
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November 6, 2023
The first-in-human trial, which aims to show the safety and tolerability of a new drug, is a major milestone for any...
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November 3, 2023
Written by Fei Tang and Evie Merinopoulou Reinforcement Learning (RL), a crucial component of machine learning (ML),...
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November 1, 2023
It feels like just yesterday I attended my first PHUSE conference back in 2005 in Heidelberg, Germany. Fast forward 19...
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October 30, 2023
The past two decades have seen the adoption of great innovation in clinical trial design. Statisticians have risen to...
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October 27, 2023
Written by Natalia Muehlemann, Vice President, Clinical Development; Martin Frenzel, Research Principal, Statistical...
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October 25, 2023
The European Union (EU) health technology assessment (HTA) regulation aims to improve the availability of innovative...
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October 23, 2023
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are the...
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October 20, 2023
Written by Grammati Sarri and Yannis Jemiai The spotlight for this year’s World Evidence-Based Healthcare Day (EBHC)...
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October 18, 2023
Written by Angelo Tinazzi and Florence Le Maulf Integrated Summaries of Safety (ISS) and Integrated Summaries of...
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October 13, 2023
Written by Alind Gupta, Cytel; Haridarshan Patel, Horizon Therapeutics; and Jason Simeone, Cytel Ophthalmology is...
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October 11, 2023
Moving beyond static evidence development to ensure local market access success; responding to recent changes in...
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October 10, 2023
Cytel’s Functional Service Provision (FSP) teams work on exciting projects with biotech and pharmaceutical companies as...
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October 6, 2023
Real-world evidence studies are becoming increasingly popular in pharmaceutical development. But to ensure such studies...
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October 4, 2023
Adaptive clinical trial designs have become increasingly popular among developers and investors due to the many...
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October 2, 2023
Patients’ adherence to the medications or treatment regimens prescribed to them by their clinicians is an important...
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September 29, 2023
In the ever-changing field of clinical trial design, there is often a need to evaluate design options quickly and...
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September 25, 2023
As the pressure to reduce timelines rises across the industry, independent data monitoring committees (IDMCs) — which...
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September 20, 2023
Cytel’s Functional Service Provision (FSP) teams work on exciting projects with biotech and pharmaceutical companies as...
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September 18, 2023
With the ongoing changes inherent in the life sciences industry comes heightened expectations for companies to take...
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September 13, 2023
Independent data monitoring committees (IDMCs) review ongoing clinical trial data to make recommendations regarding...
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September 11, 2023
As a drug developer, you have to live with the answers and comments you get from regulatory authorities. Therefore,...
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September 8, 2023
Single-arm trials, unlike placebo-controlled randomized control trials, forgo the use of a placebo or standard-of-care...
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September 1, 2023
Data is the cornerstone of any clinical trial, driving the decision-making process of drug development, and is a...
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August 30, 2023
Cytel’s Functional Service Provision (FSP) teams work on exciting projects with biotech and pharmaceutical companies as...
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August 28, 2023
A clinical development plan — a comprehensive strategy for developing an investigational product through regulatory...
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August 25, 2023
For several years, CDISC and Regulatory Data Submission expert Angelo Tinazzi has authored the series, The Good Data...
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August 22, 2023
Written by Cyrus Mehta and Heather Struntz The significant time and cost, as well as high failure rates, of clinical...
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August 18, 2023
The most common cause for incomplete Phase III trials is enrollment. Indeed, as many as 37% of trials miss...
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August 14, 2023
In the first part of this post, I discussed the ongoing revolution, or maybe I should say evolution, we are living...
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August 11, 2023
Systematic literature reviews are essential for proving product value to health authorities, clinicians, and payers,...
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August 9, 2023
How do you envision the future of data submission? Last week, I had the privilege of presenting the topic “Standards...
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August 4, 2023
“There is always the risk that interim analyses might occur after the Sufficient Information Threshold has been...
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August 1, 2023
Evaluating the efficacy and safety of novel therapies in rare indications can be challenging due to the difficulty of...
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July 28, 2023
Written by Fei Tang, RWE Senior Research Consultant, and Paul Arora, Assistant Professor (Status), Dalla Lana School of...
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July 14, 2023
Written by Grammati Sarri, David Smalbrugge, Andreas Freitag, and Evie Merinopoulou The vision of a single, centralized...
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June 20, 2023
Legislation on pediatric studies has existed for more than 20 years in the US, yet additional guidance from the FDA has...
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June 14, 2023
Medical research has come a long way in recent years, fueled by innovative trial designs that challenge traditional...
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June 9, 2023
In the ever-evolving landscape of clinical development, the need for robust evaluation of interim clinical data through...
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June 7, 2023
Since its founding in 1987, Cytel has been home to some of the most passionate, creative, and talented experts in the...
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June 5, 2023
Cytel recently announced the launch of its Therapeutics Development Team, bringing together quantitative,...
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June 2, 2023
Data submissions are very regulated, but every drug and drug development are different. Therefore, the data presented...
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May 24, 2023
As of March 2023, specifically for any study started on or after March 15, 2023,1 for the submission of SEND, SDTM, and...
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May 22, 2023
By Grammati Sarri, Evie Merinopoulou, Vinusha Kalatharan, and Jason Simeone The Canadian Agency for Drugs and...
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May 10, 2023
The evidence is staggering on the unequal health burdens experienced by specific patient groups defined by ethnic,...
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May 5, 2023
As clinical trials become more complex, simulation-guided design approaches are crucial. For this edition of the...
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May 3, 2023
With input by Alind Gupta, Louis Dron, and Jason Simeone. Randomized clinical trials (RCTs) have long been considered...
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April 26, 2023
Regular technical discussions with the FDA play a critical role in ensuring data submission success. These discussions...
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April 25, 2023
An interview with Miguel Hernán, Harvard University Kolokotrones Professor of Biostatistics and Epidemiology On March...
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April 24, 2023
In the last 10 years, the Asia-Pacific (APAC) region has become a hotspot for clinical trials: the region contributed...
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April 21, 2023
It was early March 2020, after the world was hit by the Covid-19 pandemic, that those of us on the CDISC Eu committee...
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April 18, 2023
The Inflation Reduction Act (IRA), passed in August 2022, marks a significant shift in the US healthcare landscape,...
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April 14, 2023
Real-world data and evidence are increasingly being used in health care decisions and publications. However, there are...
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April 5, 2023
Health technology assessment (HTA) submissions require cost effectiveness analyses based on comparative effectiveness...
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March 24, 2023
Last week, we featured our final Winter Weekend Read, the last in a series designed to showcase our complimentary...
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March 21, 2023
One of the lesser-known complications associated with Multiple Sclerosis is a higher risk of serious infections (SIs)....
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March 17, 2023
Smaller clinical trials can be optimized in significant ways using simulation-guided design. A small biotech studying...
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March 13, 2023
Many industries have long since adopted the practice of modeling and simulating experimental scenarios. And despite...
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March 8, 2023
Real-world data has been increasingly used to answer questions related to the course, prognosis, and treatment of...
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March 7, 2023
Health inequalities are an enduring issue that can be exacerbated by clinical trial recruitment that does not reflect...
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March 3, 2023
The speed of scientific discovery has been outpacing the ability of researchers to accumulate and integrate constantly...
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February 24, 2023
Last week, Cytel Director & Research Principal Louis Dron discussed new FDA guidance on the design and conduct of...
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February 22, 2023
Simulation-guided design is quickly becoming a novel feature of modern drug development. Its foundational promise is to...
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February 14, 2023
The U.S. FDA has recently provided specific guidance[i] on the design and conduct of trials incorporating an external...
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February 9, 2023
Those familiar with simulation-guided design (SGD) know that it can be used for a wealth of clinical trial options:...
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February 8, 2023
Over the past years, probably the entire last decade, there have been several discussions on how to handle multiple...
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February 3, 2023
For clinical development and research and development teams, the Pareto Frontier can perform two functions. Let’s take...
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January 31, 2023
Asthma affects more than 235 million people worldwide, and due to lacking effective implementation of clinical...
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January 27, 2023
Should your clinical trial be adaptive? Trials that include a prospectively planned modification based on an interim...
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January 25, 2023
People think in Bayesian terms all the time: we use prior information and the evidence at hand to make decisions in our...
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January 23, 2023
Ever since the first immune checkpoint inhibitor was approved for market nearly twelve years ago, the industry has...
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January 20, 2023
A small biotech’s conventional carcinoma trial design was too expensive to implement and did not offer the opportunity...
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January 17, 2023
When it comes to rare diseases, a handful of major challenges to drug development arise. Bayesians strategies have...
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January 13, 2023
Bayesian methods, with their ability to facilitate flexibility and learning, are often associated with early-phase...
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January 12, 2023
Statistical methods have long been fundamental to drug development, and advancements in the last few decades in...
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January 6, 2023
You may have heard that our clinical trial strategy platform Solara® won the Fierce Life Sciences award for Technology...
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January 4, 2023
Returning to Cytel after the winter holidays, I am excited to begin a year that will likely prove memorable for both my...
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December 27, 2022
Bayesian methods have been playing a key role in transforming clinical research, providing a variety of new...
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December 21, 2022
Perspectives on Enquiry and Evidence features two recurring interview series: Our new Industry Voices series, in which...
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December 19, 2022
Adaptive trial designs – that is, trials that include a prospectively planned modification based on an interim analysis...
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December 16, 2022
Bayesian methods have been playing a key role in transforming clinical research, and Bayesian topics are frequently...
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December 9, 2022
As promised in my last post prior to PHUSE-EU Connect, I’d like to now share some reflections on my “Integration...
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December 6, 2022
In this edition of the Career Perspectives series, I spoke with Veronica Chan, Principal Clinical Data Manager at...
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December 2, 2022
For 35 years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to...
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November 29, 2022
Bayesian methods have continuously played a key role in transforming clinical research in therapeutic areas such as...
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November 18, 2022
In the following interview, Dr. Parvin Fardipour, Quantitative Strategies & Data Science, sits down with Heather...
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November 14, 2022
When conducting network meta-analysis (NMA) – that is, a technique that involves comparing multiple treatments...
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November 9, 2022
In this edition of the Career Perspectives series, I interview Malte Stein, Senior Biostatistician. Malte owned the...
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November 8, 2022
Although many of you can’t wait for the start of the Football World Cup 2022 (less than two weeks while I’m writing),...
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November 3, 2022
Cytel will be represented at over 60 presentations at ISPOR Europe 2022, with more issue panels and workshops than any...
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November 2, 2022
Pharmaceutical research in oncology is increasingly focused on the development of therapies targeted at newly...
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October 28, 2022
Integrating the “pressure testing” of clinical trial designs into the process of creating a strong clinical trial...
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October 24, 2022
On the occasion of Cytel’s 35th anniversary, co-founder Professor Cyrus Mehta sits down with Dr. Esha Senchaudhuri to...
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October 18, 2022
On the occasion of Cytel’s 35th anniversary, co-founder Professor Nitin Patel sits down with Dr. Esha Senchaudhuri to...
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October 14, 2022
In this edition of the Career Perspectives series, I interview Nicolas Rouillé, Senior Director, Statistical...
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October 13, 2022
ISPOR Europe, the leading global conference for health economics and outcomes research (HEOR) and real-world evidence...
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October 11, 2022
On the occasion of Cytel’s 35th anniversary, our CEO Joshua Schultz sits down with Dr. Esha Senchaudhuri to discuss the...
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October 4, 2022
Integrated Nested Laplacian Approximations (or INLA) are now starting to be used by statisticians as a key tool for...
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October 3, 2022
The wider availability of electronic health data, medical registries, and even larger proprietary datasets means that...
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September 28, 2022
The landscape of drug development has changed dramatically over the last few decades, and effective statistical leaders...
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September 27, 2022
On Louis Dron et al., “Data Capture and Sharing in the COVID-19 Pandemic: A Cause for Concern,” The Lancet 4 (10) (2022)
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September 23, 2022
Adaptive trial designs – that is, trials that include a prospectively planned modification based on an interim analysis...
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September 16, 2022
In the first part of this article, I raised awareness of the availability of additional FDA guidances containing CDISC...
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September 15, 2022
On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022, which includes U.S. drug...
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September 12, 2022
In clinical trials, patient enrollment is often staggered, with data collected sequentially. When designing a clinical...
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September 9, 2022
A new trend has emerged over the last decade that has changed the way many clinical trials are conducted. Unlike...
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September 8, 2022
The American Statistical Association Biopharmaceutical Section, in cooperation with the FDA Statistical Association,...
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August 26, 2022
To continue our Summer Weekend Reads series, Cytel presents “Discover the Value of an Optimized Clinical Data Strategy”...
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August 25, 2022
The International Society for Pharmacoepidemiology is hosting its “ICPE 2022: Advancing Pharmacoepidemiology and...
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August 18, 2022
The American Statistical Association’s annual Joint Statistical Meeting (JSM) gathered over 6,500 attendees from 52...
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August 4, 2022
In this edition of the Career Perspectives series, I interview Allison Luccock, Director of Business Operations for...
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August 3, 2022
A number of late-phase clinical trial sponsors remain hesitant to employ Bayesian approaches in confirmatory settings,...
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July 28, 2022
When new treatments are compared with existing therapies in clinical care, population-adjustment techniques need to...
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July 27, 2022
Written by Jing Ping Yeo and Charles Warne Adaptive designs are studies that “include a prospectively planned...
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July 26, 2022
To watch this webinar and others from this introductory series, click the link below. The ability to draw on electronic...
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July 20, 2022
When performing indirect treatment comparisons, effect modification can create complexities in the event of high...
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July 13, 2022
Many thanks to Grammati Sarri and Michael Groff for their comments in developing this blog. An indirect treatment...
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July 7, 2022
The gold standard for assessing the efficacy for a medicine continues to be RCTs, however, for many reasons (disease...
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June 28, 2022
Founded in 1987 by Cyrus Mehta and Nitin Patel, research scientists at Harvard University and MIT respectively and...
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June 15, 2022
For years CDISC data standards implementers have struggled to find good implementation examples and use cases beside...
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June 14, 2022
Suppose you had to choose six clinical trials intended for registration with regulatory agencies, only six, to explain...
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June 13, 2022
The International COVID-19 Data Alliance (ICODA) was formed to address the challenge of generating rapid and rigorous...
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June 8, 2022
Clinical researchers, seeking to understand the statistical benefits of a common Phase 2 oncology design, now have a...
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June 7, 2022
In most instances of blinded sample size re-estimation, the timing of the interim analysis that determines whether the...
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June 2, 2022
How can clinicians at the forefront of modern clinical trials and statisticians at the forefront of advanced...
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May 27, 2022
When submitting systematic literature reviews to a Health Technology Assessment authority, high volumes of research...
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May 26, 2022
When constructing estimands a key question that arises is how to handle intercurrent events and missing data. In a...
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May 24, 2022
Traditionally, clinical trials are expensive, long in duration, and have low success rate. But with the advent of rich...
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May 16, 2022
A combination of industry and policy forces have recently changed the shape of Australia’s R&D sector, making it a...
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May 12, 2022
Synthetic control arm (SCA) methods are statistical methods that are seeing rapidly increasing use in comparative...
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May 5, 2022
While randomized control trials remain the industry gold-standard for regulatory and reimbursement submissions, there...
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May 4, 2022
If you are a pharmaceutical or biotech company seeking to enter the market with a new drug, you need to submit a...
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May 3, 2022
In 2005, Pfizer launched a Phase 1 trial for the kinase inhibitor crizotinib. Six years later, it was approved, thanks...
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April 29, 2022
At ISPOR US 2022, Cytel’s HEOR & RWE experts will be contributing to a range of Issue Panels, In-person Podium...
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April 27, 2022
New medicines and devices under development live and die on the strength of their clinical data. An asset’s journey is...
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April 25, 2022
I am excited to see you all at the CDISC Europe Interchange, April 27 – 28 but unfortunately, it will be a virtual...
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April 22, 2022
This past decade has undoubtedly witnessed an increase in the number of single arm trials submitted to HTA bodies....
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April 21, 2022
Sophisticated Bayesian Methods are gaining a lot of traction as they bring flexibility and speed to clinical trial...
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April 13, 2022
The Life Sciences landscape has seen an impactful digital evolution in the past two years. The pandemic has accelerated...
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April 12, 2022
In this edition of the Career Perspectives series, I interview Charles Warne, Associate Director of Biostatistics at...
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April 8, 2022
The planning and optimization of a clinical trial is beset by uncertainties: knowledge of treatment effects, the...
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April 7, 2022
Randomized control trials (RCTs) are the gold standard for estimating the efficacy of a treatment. They allow us to...
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April 5, 2022
Hello! I’m delighted to pen my inaugural blog post here as Cytel’s Chief Medical Officer. In this series, we’ll explore...
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April 1, 2022
At the end of every year, scientists from across Cytel’s business units are nominated for Cytel’s Spotlight Awards,...
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March 23, 2022
For over a decade, the number one reason cited for trial discontinuity has been challenges associated with recruitment...
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March 18, 2022
Real world evidence (RWE) provides a large and growing source of insights into drug uptake and safety. It is...
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March 11, 2022
Every year, sponsors hesitating to use a complex innovative clinical trial design routinely miss opportunities to...
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March 8, 2022
The issue of delayed treatment effects in immuno-oncology was demonstrated during a FDA-Industry sponsored workshop...
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February 22, 2022
When determining the best possible statistical design for a particular trial, large pharmaceuticals and small biotechs...
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February 18, 2022
Data is the most crucial asset of any clinical trial and hence, sponsors cannot jeopardize collecting clean...
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February 17, 2022
It is a common perception that the role of a Data Manager is only to perform what we call “Data Cleaning”; making sure...
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February 15, 2022
As the use of advanced and innovative clinical trial designs continue to rise, sponsors often wonder which estimation...
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February 11, 2022
Adopting data standards such as CDISC in the early phase of clinical drug development contributes to the consolidation...
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February 9, 2022
Data is the cornerstone of any clinical trial and is used to ultimately drive the decision-making process related to...
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February 4, 2022
The ability to conduct data-driven and quantitatively rigorous feasibility studies, is often key to successful trial...
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February 2, 2022
For nearly ten years, suboptimal trial enrollment has been cited as a primary cause of clinical trial discontinuation....
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January 27, 2022
As a part of Cytel’s 10 Year Anniversary of the Promising Zone Design, Cytel hosted a quiz on “Keeping the Promise” –...
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January 26, 2022
In this edition of the Career Perspectives series, I interview Jessica Bhoyroo, Cytel Clinical Data Manager based in...
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January 25, 2022
In this blog, I share some experiences we recently had during an FDA submission Cytel performed for a sponsor after...
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January 20, 2022
Limited patient populations resulting in small study sample sizes is a difficulty associated with the development of...
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January 19, 2022
The past two years have been transformative for Cytel. Most notably, the global COVID-19 pandemic unleashed an...
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December 23, 2021
Cytel blogs bring you debate and discussion of the newest trends in statistics and quantitative strategy. In 2021, our...
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December 20, 2021
The promising zone design is an adaptive design which allows for sample size re-estimation based on the results of an...
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December 15, 2021
Recently, on November 29 I received an email from CDISC announcing an important update for both SDTM and ADaM CDISC...
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December 14, 2021
In traditional clinical trial design, the sample size is often determined to detect the target treatment effect with...
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December 8, 2021
Despite the debate in the scientific community on adaptive sample size reassessment (SSR), noteworthy developments have...
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December 7, 2021
Sponsors bringing a successful new product to market have to overcome two hurdles: submission and reimbursement. For...
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November 30, 2021
The FDA “Real-Time Oncology Review (RTOR)”[1] is an “FDA project started in 2018 to facilitate earlier submission of...
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November 30, 2021
The aim of any clinical research is to detect the actual difference in treatment effect between two groups (power) and...
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November 23, 2021
A randomized clinical trial (RCT) is the gold standard approach to demonstrate the efficacy and safety of novel...
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November 17, 2021
Traditionally, the teams responsible for clinical development and regulatory submissions do not consult the market...
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November 15, 2021
Since its first publication ten years ago, Cyrus Mehta and Stuart Pocock’s Promising Zone Design for sample size...
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November 11, 2021
The value of Real World Evidence (RWE) is well known to many stakeholders, but its full potential for market access and...
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November 10, 2021
There are many reasons why traditional approaches to designing a clinical study are generally suboptimal and do not...
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November 8, 2021
Ten years ago Cytel co-founder Professor Cyrus Mehta and Professor Stuart Pocock of the London School of Hygiene and...
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November 4, 2021
The prominent European conference for Health Economics and Outcomes Research (HEOR), ISPOR Europe 2021, is around the...
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November 2, 2021
A good clinical study design performs well not only under the ideal target scenario. Statisticians should be able to...
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October 27, 2021
A staged investment strategy aligns R&D decisions and financial planning with the interim looks of a clinical trial. If...
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October 22, 2021
Currently, there are many treatment options for Cancer such as, Immunotherapy, Radiation Therapy, Chemotherapy etc. If...
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October 21, 2021
A number of methods currently exist to measure non-adherence and non-persistence of medical therapies, for improved...
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October 20, 2021
For health innovators, trial selection is a key success factor as there are no second chances. But how do you find the...
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October 14, 2021
When choosing the optimal clinical trial design for a given study, sponsors face critical questions like choice of...
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October 7, 2021
‘Drugs do not work in patients who do not take them,’ said former surgeon general C. Everett Koop. Unfortunately, the...
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October 6, 2021
Master Protocols are advanced and innovative clinical trial designs that can evaluate multiple therapies and disease...
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October 5, 2021
Traceability is crucial in all steps of clinical data handling, from data collection to final analysis. The importance...
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October 1, 2021
The COVID-19 pandemic elevated the challenge of designing and executing clinical trials within a substantially...
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September 30, 2021
A complex methodological issue which arises in the production of real-world evidence involves the degree to which...
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September 29, 2021
While there is a plethora of rare diseases, some 7000 diseases and counting, one needs to consider the statutory...
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September 24, 2021
We may be familiar with adaptive designs, but their complexity has made them difficult to implement and their benefits...
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September 23, 2021
A complex methodological issue which arises in the production of real-world evidence involves the degree to which...
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September 21, 2021
Earlier this summer, we published a series of articles on the need to utilize weighting and prioritization tools in the...
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September 15, 2021
There is recognized heterogeneity within any given tumor‐type from patient to patient (inter‐patient heterogeneity),...
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September 14, 2021
Alyssa Biller is a Senior Solutions Consultant at Cytel and currently plays a primary role in onboarding customers for...
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September 8, 2021
A key decision in the design of clinical trials in oncology involves whether to select progression free survival (PFS)...
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August 31, 2021
For years, I have been telling the recruiters at Cytel to be wary of candidates claiming to have a CDISC Certification...
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August 20, 2021
In clinical research, decision makers need to choose among different courses of action every day. Whether it is...
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August 18, 2021
During the design of a clinical trial, many biotechs want to substantially reduce the risk of a good new therapy being...
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August 13, 2021
With the cloud computing power that we have today, we can run simulation of 1000s of designs with each design...
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August 9, 2021
Recently we discussed examining clinical development through a Bayesian lens, in honor of Cytel co-founder Nitin Patel...
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August 5, 2021
It is important to compare competing interventions to determine value of medicines, both from clinical and societal...
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July 30, 2021
I had recently (for the first time) the pleasure and honor to attend a virtual meeting with the FDA, a pre-NDA Type-B...
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July 28, 2021
“We found an optimal design in hours that might have taken months to find using standard methods,” reflected Fabien...
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July 27, 2021
Program and portfolio optimization creates a framework throughout the course of the clinical development journey, that...
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July 22, 2021
Earlier this year, Cytel founder Cyrus Mehta observed that clinical trial design is often treated like an art rather...
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July 21, 2021
Conducting a transparent, targeted and robust benefit-risk assessment of a new drug or product is one of the most...
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July 20, 2021
Anil Golla is Vice President, Functional Service Provision (FSP) at Cytel. After 17 years of working at pharmaceutical...
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July 14, 2021
For decades, statisticians have cultivated methods to optimize and de-risk clinical trials for strong regulatory...
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July 7, 2021
Suppose a statistician were to tell a clinical trial sponsor that it was possible to improve the power of the sponsor’s...
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July 2, 2021
Popular statistical designs, such as CRM (O’Quigley et al., 1990), mTPI-2 (Guo et al., 2017), and i3+3 (Liu et al.,...
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July 1, 2021
Synthetic control arms (SCAs) are best suited for situations when a single arm trial is run in a patient population...
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June 30, 2021
When Cyrus Mehta introduced the Promising Zone Design over a decade ago, the new statistical method not only...
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June 25, 2021
The main challenge associated with the development of therapies for rare diseases is typically the small study sample...
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June 24, 2021
Synthetic control arms (SCAs) leverage real world data from various sources or evaluations of historical clinical data...
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June 23, 2021
Much of the discussion about clinical trial design considers methods to optimize performance characteristics and...
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June 18, 2021
Next week’s PSI Conference will feature Dr. Yannis Jemiai speaking on the use of Scoring Functions in the re-imagined...
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June 17, 2021
In Part 2 of this four-part blog series, we bust another myth surrounding synthetic control arms (SCAs) used in...
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June 15, 2021
Ten years ago, a seminal paper published by Cytel Founder Cyrus Mehta, introduced the Promising Zone Design to...
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June 14, 2021
ACDM’s (Association for Clinical Data Management) eDigital data management expert group (DMEG) focuses on driving...
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June 10, 2021
Over the past decade, single arm trials have emerged as an accepted way of assessing a new treatment intervention....
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June 9, 2021
When selecting clinical trial designs, how many design options should a sponsor explore? Would a sponsor feel more...
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June 4, 2021
Bayesian methods have been playing a key role in transforming clinical research in therapeutic areas such as oncology...
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June 3, 2021
Bayesian methods allow for the incorporation of prior knowledge, in terms of either expert opinion from clinicians or...
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June 2, 2021
For many decades the Pareto Frontier has been employed by actors in the private sector to evaluate and understand the...
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May 28, 2021
Advancements in biomarkers and momentum in precision medicine has paved the foundation for complex studies like basket...
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May 20, 2021
As more payers and HTA agencies turn to real world data to compare the effectiveness of various treatment effects, two...
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May 19, 2021
Clinical trial sponsors are more likely than ever to use the power of simulation and forecasting to evaluate the...
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May 14, 2021
When developing clinical strategy, applying familiar business principles to the specific requirements of clinical...
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May 13, 2021
Cytel’s HEOR and RWE Expertise has grown quite significantly in the past year. Could you speak a little bit about the...
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May 12, 2021
Did you know that Bayesian methods can strengthen Frequentist trials through the use of Bayesian decision criteria or...
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May 7, 2021
When is a study design considered to be optimal? A good design performs well not only under the ideal target scenario...
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May 5, 2021
Cytel’s team of HEOR and Real-World Evidence (RWE) experts are all set to make a splash at the Virtual ISPOR on May 17...
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April 29, 2021
After twenty years in pharma, Anna Forsythe was frustrated by traditional vendors who used outdated methods to prepare...
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April 28, 2021
Recently, Cytel co-founder Professor Cyrus Mehta noted that, “Clinical trial design selection is too much like an art,...
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April 26, 2021
As we all continue to take necessary precautions against the spread of COVID-19 virus, this year again the CDISC EU...
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April 23, 2021
The urgent need to discover and assess the efficacy and safety of COVID-19 vaccine candidates will affect the future...
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April 21, 2021
Two therapies are placed in head-to-head clinical trials when they are compared against each other as opposed to a...
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April 20, 2021
For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea...
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April 14, 2021
In the era of modern clinical development, several companies are turning towards novel and innovative approaches such...
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April 13, 2021
There has been an increasing use of digital measures in drug development recently. New wearables technologies can help...
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April 7, 2021
Scientists at Cytel recently published a paper in the Journal of the American Medical Association (JAMA). Among the...
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April 2, 2021
Earlier this month, my colleagues at Cytel Canada published a paper in JCO Clinical Cancer Informatics, offering a...
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March 31, 2021
As decentralized clinical trials become more attractive in an era of COVID-19, the role of wearables in clinical...
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March 30, 2021
As of today, our Industry has not defined any approach, nor does an official regulatory agency...
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March 26, 2021
Former Commissioner of the FDA, Dr. Scott Gottlieb, in several public presentations, would bemoan missed chances to...
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March 25, 2021
Wearables have experienced increasing applicability within medical device trials, yet the regulations for the use of...
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March 19, 2021
The use of wearable and digital technology requires considerations for both drugs and devices regulations, and...
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March 18, 2021
Over the past ten years High-Performance Computing (HPC) has transformed medical research through advances in genomics,...
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March 12, 2021
With wearables likely to become a regular part of clinical trial design, statisticians could benefit by familiarizing...
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March 11, 2021
In the recent years, Oncology trials are seeing a technological shift that is expected to make them faster and more...
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March 9, 2021
When statistical sciences were in their infancy, the communicative benefits of statistics were widely touted. Thousands...
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March 5, 2021
Early stage Phase 2 clinical trials are often designed as multi-stage single arm trials, which quickly identify...
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February 26, 2021
In the world of clinical trials, the pace of innovation is accelerating, and approaches such as Bayesian methods are...
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February 25, 2021
The convergence of several distinct trends has made wearables an increasingly attractive option for use in confirmatory...
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February 24, 2021
In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM....
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February 19, 2021
C-Suite and R&D Decision-Makers are always striving to make evidence-driven decisions. Yet the rules by which evidence...
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February 18, 2021
In the last few years, there has been a growing interest in historical borrowing or augmented trials. There is an...
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February 17, 2021
The COVID-19 Pandemic prompted the rapid surge in the generation of clinical data that has been scattered across...
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February 12, 2021
In recent times, Single arm trials are being increasingly used to assess new treatment interventions. They establish...
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February 11, 2021
The past two years have witnessed a heightened interest in the use of wearables in clinical development. The unexpected...
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February 4, 2021
The past decade has witnessed the rise of simulations-based clinical trial optimization in a manner unimaginable to...
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February 2, 2021
As the use of master protocols becomes more prevalent in drug development, Bayesian methods are extensively used to...
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February 1, 2021
Cytel’s COVID-19 Trial Tracker continues to provide real time updates to the status of COVID-19 clinical trials...
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January 29, 2021
Historically, advances in the statistical design of clinical trials have accompanied progress within the science and...
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January 28, 2021
The Christmas break presented an opportunity to make my first concrete steps into the CDISC Library. Overall, it was a...
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January 26, 2021
Bayesian models offer a flexible way of incorporating historical controls in the analysis of trial data (whether single...
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January 22, 2021
COVID-19 has transformed the pharmaceutical industry in a manner that few could have predicted only a year ago. One of...
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January 20, 2021
One of the most difficult challenges facing Research and Development teams involves determining how to make tradeoffs...
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January 19, 2021
As we enter 2021 with new COVID-19 vaccines and greater optimism about the pipeline of drugs and devices positioned for...
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January 13, 2021
Effective use of the right outsourcing solution can enable sponsors to respond to market needs and change course where...
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January 12, 2021
The rapid pace of technology has opened up numerous avenues for advanced innovative clinical trial design, but how can...
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January 11, 2021
In April 2020, Cytel launched an open-access global COVID-19 Clinical Trial Tracker to help facilitate greater...
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December 22, 2020
At Cytel, we have been diligently working to become an organization deeply committed to uplifting and enriching...
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December 21, 2020
2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog...
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December 18, 2020
Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit...
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December 17, 2020
As Chief Scientific Officer, Dr. Yannis Jemiai plays a pivotal role in maintaining Cytel’s well-established reputation...
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December 16, 2020
As we prepare to close the door on 2020, we asked Pantelis Vlachos, Principal/Strategic Consultant for Cytel, to share...
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December 15, 2020
When designing clinical trials, biostatisticians and clinical development teams are often faced with a conundrum. Given...
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December 10, 2020
Sachin Sobale began his career with Cytel as a young statistician. He has been associated with the company for more...
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December 9, 2020
As a part of Cytel’s Advanced Design Framework, a new Framework for the statistical design of clinical trials, Cytel...
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December 8, 2020
The Cytel COVID-19 Trial Tracker brings you an up to the minute, real time dashboard about COVID-19 trials around the...
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December 3, 2020
Increasing Clinical Development Productivity Using Statistics and Cloud-Computing The need for Re-imagining Clinical...
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December 1, 2020
An extraordinary amount of global research is underway as the COVID-19 pandemic continues to evolve and spread. As...
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November 24, 2020
Virtual ISPOR 2020, held November 16 to 19, presented new opportunities for scientific interaction amongst HEOR...
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November 23, 2020
The Virtual PHUSE-EU CONNECT Conference was held from November 8 to 13 and the event was a great success, despite all...
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November 19, 2020
Data Monitoring Committees (DMCs) are groups of independent experts who periodically receive (by-arm) reports created...
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November 18, 2020
The current state of the clinical trials industry faces a challenge that was only hypothetical three or four years ago....
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November 17, 2020
As a part of Cytel’s "New Horizons Webinar Series", Alind Gupta, Senior Data Scientist, presents case studies from his...
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November 16, 2020
MUCE is a Bayesian solution for cohort expansion trials where multiple dose(s) and multiple indication(s) are tested in...
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November 12, 2020
Cytel and Ingress Health (now a Cytel company) will be contributing to a range of events at Virtual ISPOR EUROPE 2020,...
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November 11, 2020
The widespread use of cloud-computing has altered the clinical trial design process. Whereas three or four years ago,...
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November 9, 2020
As the evolving COVID-19 pandemic continues, the Cytel COVID-19 Trial Tracker continues to bring you an up to the...
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November 5, 2020
In oncology, many manufacturers go into niche indications, where there are very specific tumors, and then they opt for...
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November 4, 2020
Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought leaders that draws on...
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November 3, 2020
When an expert statistician is paired with an experienced set of data managers, opportunities to capitalize on...
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November 2, 2020
Measuring treatment effect during a clinical trial is often the source of much debate, particularly during rare disease...
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October 29, 2020
Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought leaders that draws on...
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October 28, 2020
About three years ago, Cytel was helping a sponsor on a project where I had to conduct surveillance of some CRO...
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October 27, 2020
Cytel recently conducted a webinar on Bayesian Dose-finding Designs for Modern Drug Development, presented by Dr. Yuan...
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October 26, 2020
Pharmaceutical and biotech companies are under pressure to deliver more and deliver faster with fewer resources. The...
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October 23, 2020
Cytel’s New Horizons Webinar Series introduces you to the latest innovations in statistical trial design. This webinar...
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October 22, 2020
In this two-part blog series, we interview Bart Heeg, Vice President HEOR and Founder at Ingress Health (A Cytel...
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October 21, 2020
Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought-leaders after a decade...
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October 20, 2020
In this interview with Thomas Wilke, Principal Scientist at Ingress-Health (a Cytel company), we talk to him about his...
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October 19, 2020
COVID-19 has created extreme uncertainties -- a dearth of historical information combined with the need for safety,...
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October 15, 2020
For over a decade, advanced trial design techniques have promised efficient trials with accelerated timelines,...
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October 14, 2020
A credible evidence base is needed to support and document the economic value of new technologies and therapeutic...
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October 13, 2020
The combination of greater access to electronic health records, bigger electronic claims datasets, and the need for...
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October 12, 2020
Cytel and Novartis are together hosting a complimentary Bayesian Virtual Symposium and an Interactive 7-part workshop....
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October 7, 2020
With the rise in digital technologies, there has been an explosion in the volume and type of data sources. We can...
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October 1, 2020
Methods involving Group Sequential Designs are one of the earliest deviations from a traditional two-arm clinical trial...
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September 29, 2020
Innovation in trial designs are offering new routes forward for organizations of any size. They are now also aligned...
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September 25, 2020
Regulators in both the United States and Europe have responded positively to the use of synthetic control arms (SCA)s...
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September 22, 2020
Research Scientists, Thomas Wilke and Sabrina Mueller recently published a manuscript on “Diabetes-Related...
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September 17, 2020
Keeping up with the rapid pace of clinical development means that we need to adopt the innovative or computationally...
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September 16, 2020
Synthetic control arms (SCA) are virtual trial arms that use historical claims data and observational data to simulate...
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September 15, 2020
In clinical trials with small or sparse data, statistical methods meant for large sample sizes may not be helpful to...
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September 14, 2020
“A good start is half the battle” (the Before) when submitting data to the FDA and there are a couple of cherries to...
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September 10, 2020
Single arm trials are emerging as an accepted way of assessing a new treatment intervention. They establish clinical...
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September 9, 2020
Cytel’s co-founder, Nitin Patel, conducted a webinar on designing clinical trials from a program-level perspective. His...
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September 4, 2020
On Friday September 11, Cyrus Mehta, co-founder of Cytel, will be delivering a talk to the Heart Failure Collaboratory,...
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September 1, 2020
In this blog, Cytel's SVP Corey Dunham’s talks about our Functional Services teams and the qualities we seek in new...
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August 31, 2020
Pantelis Vlachos, Principal, Strategic Consultant at Cytel, conducted a webinar to introduce the capabilities of East...
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August 26, 2020
As Chief Scientific Officer, Dr. Yannis Jemiai plays a pivotal role in maintaining Cytel’s well-established reputation...
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August 25, 2020
It is important to take a strategic approach to clinical development in order to minimize the potential for Phase 3...
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August 21, 2020
As uses of real world data become more familiar for trial design and regulatory submission, sponsors might become more...
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August 18, 2020
Mrudula Joshi joined Cytel in July 2005 as a young SAS programmer. Last month, she celebrated her 15th year work...
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August 12, 2020
Cytel’s Biostatistics and Statistical Programming team provides integrated solutions, by blending the expertise of...
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August 11, 2020
While there is increasing optimism about the discovery of a COVID-19 vaccine, one of the less talked about aspects of...
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August 7, 2020
Recently a biotech approached Cytel for support with a Phase 2 Study in oncology. Regulators had requested a natural...
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August 5, 2020
Cytel is conducting two pilot projects on head-to-head comparisons using real world data. These projects in oncology...
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August 4, 2020
Last year, Paul Terrill, Associate Principal of Strategic Consulting at Cytel, presented an engaging webinar on the...
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July 30, 2020
A new peer-reviewed article co-authored by several Cytel scientists re-examines the way in which adaptive trials are...
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July 28, 2020
CDISC standards have been around for a while with the first SDTM Standard version released in 2004. However, it was...
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July 27, 2020
Cytel is conducting a webinar series on complex innovative trial designs. Dr. Thomas Burnett, Senior Research Associate...
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July 23, 2020
Just as there are numerous adaptations that fall within the umbrella of adaptive designs, there are several different...
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July 22, 2020
Cytel brings to you a new blog series on technology and Bayesian decision-making by Pantelis Vlachos,...
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July 15, 2020
Unlike many therapeutic areas, oncology benefits from having standardized endpoints like overall survival and...
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July 14, 2020
Cytel SVP Corey Dunham’s inaugural post on leading the industry’s largest Biometrics CRO considers the FSP Engagement...
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July 13, 2020
Cytel is hosting a complimentary webinar series that introduces biostatisticians and other members of the development...
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July 11, 2020
Last week we challenged you to take a COVID-19 Clinical Development Quiz. Many of you used our Trial Tracker to find...
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July 9, 2020
There has been an increased use of synthetic control arms for regulatory submissions in recent years, with three rare...
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July 7, 2020
Having its roots in the seminar rooms of the Dana Farber Cancer Institute, Cytel has a long record of establishing new...
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July 2, 2020
There are currently 1570 registered clinical trials for COVID-19 therapies and vaccines. Approximately 20% are...
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June 29, 2020
From the time the COVID-19 outbreak was declared a pandemic, the number of studies conducted around the world to either...
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June 27, 2020
Expert statisticians at Cytel have spent the past three and a half months designing and deploying dozens of trials for...
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June 22, 2020
Cytel scientists recently published a new eBook on synthetic control arms and a new scientific primer for the more...
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June 18, 2020
One of the revelations of the COVID-19 pandemic is that the flexibility and potential of Bayesian designs goes far...
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June 18, 2020
A number of trials recently disrupted by the COVID-19 pandemic are now in the process of re-assessing recruitment...
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June 13, 2020
The Cytel COVID-19 Trial Tracker continues to bring you an up to the minute, real time dashboard about COVID-19 trials...
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June 10, 2020
Cytel is conducting a webinar series that introduces biostatisticians to some of the more commonly used complex...
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June 9, 2020
Trevor Mundel leads the Bill & Melinda Gates Foundation’s efforts to develop high-impact interventions against the...
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June 8, 2020
Cytel has recently published a new ebook on synthetic control arms, and a new scientific primer as well.
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June 4, 2020
This weekly snapshot gives you a quick briefing on the state of COVID-19 therapy and vaccines development. As we head...
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May 29, 2020
At the close of May 2020, we have about 500 new trials globally but trends in trial design and choice of therapies...
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May 27, 2020
In this blog, we speak with Christopher Jennison, Professor of Statistics at the University of Bath, UK. Professor...
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May 22, 2020
The Cytel Trial Tracker now features summary plots that display trials by country, trial status and study design. This...
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May 14, 2020
This has been an exciting week for COVID-19 studies. We learned that several Cytel clients who have designed new...
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May 12, 2020
In our previous blog, “Remote Working Arrangement – How to get it right?”, we talked about how the need for social...
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May 7, 2020
There are now over 950 trials registered, which means that 250 new trials were registered in the past week. Only 540 of...
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May 5, 2020
Cytel's team of oncology trial design and advanced analytics experts are hosting a series of complimentary webinars...
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April 29, 2020
In our previous blog, we spoke with Alind Gupta, who works as a Machine Learning Researcher at Cytel in Canada. The...
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April 27, 2020
In the first part of this two-parts blog, I speak about how the European CDISC Committee (E3C) together with CDISC...
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April 24, 2020
In early March, when countries around the world started implementing lockdowns, the European CDISC Committee (E3C)...
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April 23, 2020
Cytel is hosting a webinar, “A Clinician’s Perspective on Cancer Drugs Development”, on April 28, 2020. Our speaker,...
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April 23, 2020
Every Week Cytel Brings You Further Insights from the COVID-19 Trial Tracker From April 8 through April 17, the number...
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April 20, 2020
Cytel is hosting a webinar on Transparent Machine Learning in Oncology, on April 21, 2020. Our speaker, Alind Gupta,...
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April 7, 2020
Cytel has industry-leading experts in Statistical Programming with years of SAS® Programming expertise and in-depth...
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April 2, 2020
On March 16, the World Health Organization (WHO) Director-General, Dr. Tedros Adhanom Ghebreyesus, in his media...
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March 31, 2020
Since 1953, when the discovery of the structure of DNA was made, we have seen great advancements in genomics....
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March 26, 2020
Further regulatory guidance has been released concerning the implications of the Coronavirus disease (COVID-19) on...
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March 23, 2020
On March 20th the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA)...
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March 19, 2020
The FDA issued a guidance yesterday on how the COVID-19 Pandemic may affect the conduct of clinical trials. Below are...
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March 5, 2020
Generating high-quality clinical data is a vital but challenging task in modern drug development. Unfortunately, in the...
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February 25, 2020
Over the past decade, a new trend began to emerge, changing the way that clinical trials are conducted. Whereas...
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February 25, 2020
Regulators in both the United States and Europe have responded positively to the use of SCAs in clinical...
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February 20, 2020
It is widely acknowledged among drug developers that one of their most important assets is the data generated during...
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January 30, 2020
The Cytel Trial Design Innovations (CTDI) Webinar Series recently hosted a webinar on designing event-based studies....
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January 22, 2020
In the quest for clinical success, we all strive for evidence packages of the highest quality. If the clinical data is...
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January 16, 2020
January’s Cytel Trial Design Innovations (CTDI) Webinar Series will feature Biostatistician and pioneering Bayesian...
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January 8, 2020
In clinical development, data is the vital ‘foundation’ that supports your programs. To successfully bring a promising...
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December 16, 2019
Cytel Inc. and Axio Research joined forces in June 2019, expanding our ability to solve the most complex analytical...
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December 10, 2019
In association with Statisticians in the Pharmaceutical Industry (PSI) , UCB and Cytel hosted a symposium on September...
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December 5, 2019
Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel In...
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December 2, 2019
Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel...
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November 27, 2019
At the 2019 Challenges in Rare Diseases Clinical Trials Symposium and East training, Cytel partnered with Alexion to...
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November 21, 2019
Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel In my...
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November 14, 2019
Market access strategy is an integral part of the clinical development process to ensure success in global healthcare...
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November 5, 2019
Cytel is delighted to have Kannan Natarajan speaking at the “Complex Innovative Trial Design Symposium and East User...
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October 23, 2019
October 3, 2019 was an important day for the ADaM team as it marked the release of the ADaM Implementation Guidance...
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October 10, 2019
A disease is generally considered to be rare if it affects one patient per 200,000 people (1) and most rare diseases...
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September 12, 2019
"If you went to bed last night as an industrial company, you're going to wake up today as a software and analytics...
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August 23, 2019
In place of collecting data from patients recruited for a trial who have been assigned to the control or...
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August 14, 2019
This article was originally published as part of a series by pharmaphorum in association with Cytel and is reproduced...
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August 7, 2019
In this blog, from our career perspectives series, we talk with Jayshree Garade Associate Director, Statistical...
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August 1, 2019
The term biomarker signature describes the behavior of a set of biomarkers that define a signature to maximize the...
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July 22, 2019
Health economics and adaptive design methods share common ground in that they both aim to support more efficient and...
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July 8, 2019
Cytel recently hosted a very well-attended and engaging webinar on the topic of “Estimands, not just a statistical...
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June 27, 2019
By Nicolas Rouillé and Eric Henniger The right design and the right data ultimately leads to the right decisions, so...
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June 14, 2019
This article was originally published as part of a series by pharmaphorum in association with Cytel and is reproduced...
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May 7, 2019
Nowadays, it’s difficult to pick up a mainstream newspaper or read an industry publication without seeing reference to...
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April 24, 2019
In this blog, Alla Muchnik, Senior Clinical Data Manager at Cytel, discusses how specialist CROs can add value and...
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April 10, 2019
In this blog, Jonathan Pritchard, Director Business Development at Cytel, draws on his experience in commercial,...
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March 26, 2019
At the Partnerships in Clinical Trials Conference in Barcelona in November 2018, Strategic Consultant Ursula Garczarek...
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March 20, 2019
No one plans to have a trial whose data collection needs rescuing. However, lagging enrollment rates, operational...
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February 28, 2019
In honor of Rare Disease Day 2019 we share a new Cytel podcast featuring Cytel Strategic Consultant Ursula Garczarek...
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February 21, 2019
In 2018, Cytel ran a qualitative survey among biostatisticians and programmers on trends in data science and...
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February 8, 2019
A 2018 publication in the Biometrical Journal by Cytel’s Cyrus Mehta, Lingyun Liu and Sam Hsiao, ‘Optimal Promising...
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January 10, 2019
Nand Kishore Rawat is a Director and Head, Early Phase Biostatistics based in the King of Prussia, PA Cytel office. We...
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December 5, 2018
In this blog, Paul Terrill, Director of Strategic Consulting at Cytel outlines his blueprint for ensuring smooth...
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November 27, 2018
This is the third in our blog series ' The Good Data Submission Doctor' in which Angelo Tinazzi, Director of Standards,...
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November 12, 2018
In this blog, we talk with Robert Greene, Founder and President of the HungerNDThirst Foundation, about his upcoming...
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November 8, 2018
Data is the most crucial asset in any clinical trial and is used to ultimately drive the decision-making process...
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November 5, 2018
Cytel biostatisticians Cyrus Mehta and Lingyun Liu, together with Charles Theuer, CEO of TRACON Pharmaceuticals have...
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November 1, 2018
In this second post of the “Good Data Submission Doctor” ( read my first post The Master Recipe: Quality and Attention...
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October 23, 2018
Cytel data scientists apply advanced statistical techniques including predictive modeling of biological processes and...
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October 5, 2018
We are delighted that Stephen Senn will be joining us at the EUGM on November 14th and 15th in Darmstadt, Germany. In...
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October 1, 2018
One of my wife’s favorite TV shows is ‘Quattro Ristoranti’ (Four Restaurants). In each episode of the show, 4...
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September 27, 2018
In this blog, we talk with Heiko Götte, Senior Expert Biostatistician at Merck about his upcoming presentation at...
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September 20, 2018
At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking...
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September 17, 2018
Immunotherapy has brought us many promises, most notably, of a future where humans are able to harness their body’s own...
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September 10, 2018
The biopharmaceutical and healthcare industries now collect more data than ever before due to advances in the variety...
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September 7, 2018
On August 29th 2018, the FDA announced (1) that it would be establishing a Complex Innovative Trial Design (CID) Pilot...
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September 5, 2018
EnForeSys is Cytel’s tool for patient recruitment planning. We have discussed on the blog recently with Tufts...
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August 31, 2018
JSM 2018, ASA’s annual gathering of over 6500 attendees attracted statisticians and data scientists to the beautiful...
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August 23, 2018
Cytel has grown significantly over the last 30 years, with operations across North America, Europe, and India. All of...
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August 21, 2018
After having spent 15 years in the pharmaceutical industry, in May of 2018, I decided to explore new horizons and took...
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August 15, 2018
Cytel’s 7th East User Group Meeting (EUGM) will take place on November 14 & 15, 2018 at Merck in Darmstadt, Germany,...
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August 1, 2018
By Gordhan Bagri and Munshi Imran Hossain with H A S Shri Kishore Shiny (from RStudio) is one of the most popular R...
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July 27, 2018
In this blog, we share a new infographic based on this popular blog post illustrating some of the critical interactions...
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July 24, 2018
At Cytel our strategic consulting team works on a wide range of projects including: Identifying the best clinical trial...
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July 18, 2018
A recent article published by Cytel authors Samadhan Ghubade, Sharayu Paranjpe, Kushagra Gupta, Anil Gore and colleague...
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July 16, 2018
In this blog we share a case study of how we established and ramped up a functional service outsourcing partnership for...
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July 3, 2018
It’s shaping up to be a busy year for Cytel’s software development team with a number of upgrades and planned launches...
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July 2, 2018
A number of the Cytel team were in Amsterdam, 3rd- 6th June 2018 for the PSI Conference. This year’s conference was...
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June 28, 2018
By Esha Senchaudhuri With thanks also to Jitendarreddy Seelam and Ramanatha Saralaya for their input. The fact of the...
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June 19, 2018
At the recent PCMG conference in Malta, Adrian Otte ( Independent Consultant, formerly VP Global Development Operations...
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June 14, 2018
In this blog, Paul Fardy, Executive Director of Data Management at Cytel shares his thoughts on how the data manager...
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May 23, 2018
Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic...
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May 16, 2018
Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic...
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May 9, 2018
As we prepare to head to ASCO in under a month's time, we are pleased to share a new ebook that showcases some key...
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April 25, 2018
Data management is an essential building block for successful Immuno-Oncology (I-O) trials. At the Immuno-Oncology...
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April 18, 2018
Our recent Clinical Biometrics Survey explored the views of respondents from across the statistical programming,...
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April 13, 2018
We return to our discussion with Ken Getz of the Tufts CSDD for part 2 of our blog post on key challenges in clinical...
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April 5, 2018
Photo by J. Kelly Brito on Unsplash Research on clinical trial enrollment makes for sobering reading, characterized by...
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April 3, 2018
By Esha Senchaudhuri In response to its R&D productivity from 2005 – 2010, AstraZeneca took the initiative in 2011 to...
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March 16, 2018
At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking...
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March 14, 2018
Photo by Agê Barros on Unsplash by Natalie Fforde, Senior Director of FSP Services at Cytel With effective use of...
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March 8, 2018
Photo by Steinar Engeland on Unsplash By Ivan Navarro, Data Scientist at Cytel R is an open-source implementation of...
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March 6, 2018
Photo by Dose Media on Unsplash By Charles Liu, Senior Product Manager, Cytel Several years ago, I was one of few...
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February 28, 2018
There is a consensus in the industry that data on rare diseases is limited, incomplete, and difficult to find or...
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February 27, 2018
We extend our congratulations to Lipopharma and the CLINGLIO project consortium on their recent 6,15M€ grant award by...
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February 21, 2018
By Diganta Bose, Statistical Programming Team Lead at Cytel Editor's note: This blog is based on work presented at...
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February 15, 2018
A recent publication in Biometrics ‘A Gatekeeping Procedure to Test a Primary and a Secondary Endpoint in a Group...
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February 13, 2018
Our strategic consulting team work on projects such as: Identifying the best clinical trial design, implementing...
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February 6, 2018
We were excited to learn recently that Ajay Sathe, the CEO of our India Operations, was awarded lifetime honorary...
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January 23, 2018
News Medical interviewed Dr. Rajat Mukherjee, Statistician, and Director of Data Science at Cytel to investigate the...
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January 15, 2018
The problem of feature selection The explosion in the availability of big data has made complex prediction models a...
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January 9, 2018
Our Career Perspectives' series is back! Cytel has industry-leading experts in statistical programming with years of...
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December 12, 2017
Signal management is one of the most audited pharmacovigilance processes. It also generates one of the highest findings...
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November 28, 2017
In this blog we turn to some reading matter, and interview Gautier Paux and Alex Dmitrienko about the recent book...
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November 22, 2017
Cytel offers a full range of clinical data management services and the team of experts is spread across the globe. In...
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November 15, 2017
Each year Halloran Consulting Group hosts‘CORE’ (Clinical Operations Retreat for Executives) as a forum for industry...
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November 9, 2017
In this blog we are excited to unveil a new project which we have been hard at work on over the last few months. 2017...
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October 31, 2017
As part of Cytel's new Trial Innovations Webinar Series, Pat Mitchell, Statistical Science Director at AstraZeneca...
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October 27, 2017
In this blog, we share the second part of our interview with Bob Beckman, about a design concept for a confirmatory...
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October 18, 2017
Cytel's new Trial Innovations Webinar Series provides a platform for the most promising new statistical approaches...
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September 29, 2017
Namrata Deshpande, Senior Team Lead will be participating in a round table discussion at the Women in Statistics event...
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September 20, 2017
In this blog we share a case study of work our strategic consulting team conducted supporting accurate event prediction...
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September 18, 2017
By Ashwini Joshi For small sample data or rare events data, exact non-parametric tests perform better than asymptotic...
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September 13, 2017
Antibiotic resistance is one of the greatest challenges facing human health today. We are excited to welcome Dr. Scott...
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September 11, 2017
At the East User Group meeting (EUGM) on 25th and 26th October, we will welcome a number of renowned industry speakers...
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September 7, 2017
By Munshi Imran Hossain, Software Affiliate at Cytel Biomedical signals are electrical signals collected from the body....
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August 2, 2017
As a biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and...
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July 26, 2017
Sadly, clinical development of anti-cancer therapeutics faces particularly high rates of failure, even in the context...
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July 19, 2017
With adaptive and innovative trial designs on the rise, operational implementation of interim analyses, including...
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July 13, 2017
By Tejasweeni Rajput It’s been known for centuries that a picture can tell a thousand words. In an era of new...
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July 11, 2017
The Adaptive Designs and Multiple Testing Procedures Workshop (ADMTP), the first joint meeting of the Adaptive Designs...
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July 6, 2017
By Esha Senchaudhuri The ethical benefits of adaptive clinical trials have been widely acclaimed: higher prospects for...
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June 28, 2017
About the Author: Manjusha Gode has over 28 years' IT experience spanning delivery Management, quality management,...
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June 12, 2017
The Population Approach Group in Europe (PAGE) represents a community with a shared interest in data analysis using the...
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June 8, 2017
Cytel's Madhusmita Panda presented at this year’s PSI Conference in the Innovative Methodology session on the topic of...
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May 30, 2017
A recent paper The case for Bayesian methods in benefit-risk assessment: Overview and future directions (1) co-authored...
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May 26, 2017
PharmaSUG 2017 proved to be an inspirational and informative event. With over 200 paper presentations, posters, and...
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May 22, 2017
James (Jim) Bolognese, Senior Director, Strategic Consulting, Clinical Services at Cytel Inc. was named a 2017 fellow...
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May 17, 2017
This new case study shares how Cytel supported a specialist biopharmaceutical company from Phase 2 trial design through...
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May 4, 2017
As a recognized expert in adaptive trials, Cytel has extensive experience designing and managing trials with interim...
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April 28, 2017
In this blog we share a case study in which our statistical consulting team helped a client redesign an oncology...
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April 25, 2017
At a recent conference Adam Hamm, Director Biostatistics at Cytel, presented his thoughts on Best Practices and...
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April 11, 2017
In a January 2017 paper (1), the FDA reviewed 22 case studies where promising Phase 2 trials did not result in...
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April 5, 2017
Statistical programmers at all levels can make a significant impact on streamlining delivery, improving efficiency, and...
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March 29, 2017
With an increasing interest in platform designs and other innovative designs that involve multiple comparisons over...
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March 24, 2017
Robust go/no-go (GNG) decision-making is essential for effectively managing risk across a clinical portfolio. In early...
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March 20, 2017
In the randomized clinical trial (RCT), the process of deciding the randomization method and implementing is critically...
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March 15, 2017
A precise and thorough approach to planning is key for success in data management. The Data Management Plan (DMP) is a...
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March 10, 2017
At the recent Biosimilars Summit in Philadelphia, Cytel's Pantelis Vlachos presented on statistical challenges and...
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March 2, 2017
We continue our case study series with this example of a Phase 3 design that uses Bayesian decision making combined...
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February 27, 2017
It’s been hard to miss the prevalence of estimand-related discussions in the last year. This is a topic which is very...
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February 21, 2017
In a previous blog, we provided an overview of basic data structures in R. In this follow up piece, we will provide a...
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February 15, 2017
Outsourcing solutions should never be a one size fits all process, and smaller and emerging biopharma companies may...
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February 9, 2017
In this blog, Adam Hamm, PhD, Director Biostatistics at Cytel shares some of the most important knowledge he uses in...
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February 6, 2017
CDISC is a global, nonprofit charitable organization whose mission is ‘to inform patient care and safety through higher...
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January 30, 2017
Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies. They...
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January 23, 2017
As a group, Cytel had over 40 successful regulatory interactions last year, many of which supported approvals for...
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January 19, 2017
R is on the rise in biopharma, and as we have previously discussed on the blog, it is now time for SAS programmers to...
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January 16, 2017
The Global Cardiovascular Clinical Trialists Forum is a key event bringing together leading experts from across the...
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January 5, 2017
Nonlinear Mixed Effects Modeling (NONMEM) is a type of population pharmacokinetics/pharmacodynamics (popPK/PD) analysis...
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December 21, 2016
December 18th 2016 was a significant date for the pharmaceutical industry and regulatory submissions. For trials which...
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December 20, 2016
Data Standards play a crucial role in structuring and promoting long term value of clinical data. Clinical Data...
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December 15, 2016
In April, we interviewed NIHR research fellow Munya Dimairo about the paper, ‘Adaptive designs undertaken in clinical...
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December 13, 2016
In the complex world of trial design and data analysis biostatisticians and data scientists need to ensure they are...
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December 6, 2016
The management of quality clinical data collection is built on a number of core essentials- including project...
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December 2, 2016
At a recent Pfizer/ Cytel seminar on rare disease and oncology development, Cytel’s Lingyun Liu presented innovative...
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November 21, 2016
While adaptive designs can deliver significant benefits to clinical development- including ethical benefits for...
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November 18, 2016
Challenge Our client had the following key questions which they wanted our pharmacometrics group to address for an...
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November 14, 2016
In our last blog, we shared some of Angelo Tinazzi and Cedric Marchand's recommendations on how to ensure independence...
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November 11, 2016
A solid and robust QC process is one vital component of ensuring quality programming delivery. Angelo Tinazzi and...
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November 9, 2016
Adaptive sample size re-estimation designs are an important part of the statistician's toolkit. In this first in a...
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November 1, 2016
Unlike statistics which has been around in some form for hundreds of years, pharmacometrics is, by comparison, a...
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October 25, 2016
Use of R is a hot topic among statisticians and programmers in the pharmaceutical industry. At the recent PhUSE...
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October 13, 2016
Statistical programmers play a key role in turning the data from clinical trials into knowledge and supporting the...
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October 11, 2016
Its important to take a strategic approach to clinical development in order to minimize the potential for Phase 3...
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October 7, 2016
Adaptive designs have the potential to accelerate clinical development, and improve the probability of trial success....
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October 5, 2016
While some progress has been made in terms of scientific development in Neuroscience and Neuropsychiatry indications,...
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September 29, 2016
A paper "Best practices case studies for 'less well-understood' Adaptive designs", has been published by the DIA...
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September 27, 2016
The Lung-MAP trial is an innovative biomarker driven 'precision medicine' study which evaluates five novel agents for...
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September 20, 2016
Drug development is an expensive and risky business. To maximize a compound’s ultimate chances of commercial as well as...
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September 13, 2016
Exposure-response data gained from clinical studies can provide a basis for model-based analysis and simulation,...
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September 9, 2016
Challenge: Our client, an emerging biotechnology company, was preparing for the next stage of development for their...
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September 7, 2016
In the 2010 draft FDA ‘Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics', the agency...
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August 31, 2016
Traditional rule-based approaches to dose escalation such as 3+3 are widely used in early clinical development. They...
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August 26, 2016
At the recent JSM in Chicago, Cytel’s Sam Hsaio and Lingyun Liu alongside Genentech's Romeo Maciuca, presented a...
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August 23, 2016
At the recent JSM meeting in Chicago, Cytel's Jim Bolognese presented the results of work he has conducted evaluating...
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August 17, 2016
Following the recent publication of their review article Adaptive Designs for Clinical Trials in the New England...
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August 9, 2016
At the recent JSM Meeting, Cytel’s Yannis Jemiai presented the case study of the VALOR trial which used a promising...
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August 2, 2016
Editor's note( this blog was refreshed in April 2018) As CDISC compliant submissions become increasingly expected,...
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July 28, 2016
To close a clinical database right the first time you have to begin with study start-up. Clearly, you can’t close a...
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July 25, 2016
Statistical programmers are in high demand within the biopharmaceutical industry, and within the dynamic world of...
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July 21, 2016
Did you miss our webinar on Single and Dual Agent Dose escalation designs earlier in the year? In this blog we have...
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July 18, 2016
In order for adaptive designs to reach their potential, it’s critical that knowledge is effectively dissemirnated...
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July 12, 2016
How do you go about selecting the best Electronic Data Capture (EDC) system for your study? There is now a vast amount...
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July 7, 2016
Why do we do what we do? At Cytel we have always been driven to deliver benefits in the service of human health, and...
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July 5, 2016
At a recent PhUSE SDE, Cytel’s Chitra Tirodkar presented how East PROC MCPMod could be used to help solve the problem...
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June 23, 2016
Vendor selection is a critical component of ensuring clinical trial success. A 2015 report (1) suggested that clinical...
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June 21, 2016
Sunil is an Associate Director of Statistical Programming at Cytel and has over twenty-five years of experience in the...
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June 16, 2016
Predicting the course of a clinical trial is something which people will always want to do-whether for statistical...
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June 14, 2016
At Cytel, we are very often asked to get involved in DMCs ( Data Monitoring Committees) in a variety of capacities. Our...
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June 7, 2016
At the recent CMO Summit East James ( Jim) Bolognese, Cytel’s Senior Director of Strategic Consulting, and Lou...
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May 31, 2016
Last week, we were delighted to announce the release of East 6.4 bringing further cutting –edge approaches to the East...
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May 19, 2016
The explosion in healthcare information and “big data “has been one of the most written about topics in the last few...
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May 17, 2016
Cytel participated at PharmaSUG 2016 in Denver recently. A key event on the statistical programming global calendar,...
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May 12, 2016
Once upon a time Hansel and Gretel laid a trail of breadcrumbs which they followed to find their way back home. Their...
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May 10, 2016
We were fortunate to welcome Björn Bornkamp of Novartis to the EUGM 2016 presenting work he has developed jointly with...
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April 28, 2016
Adaptive Designs in Practice: Interview with NIHR Research Fellow Munya Dimairo NIHR and University of Sheffield...
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April 26, 2016
In this blog we’ll highlight some unique challenges that are encountered from a Data Management perspective when...
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April 22, 2016
FDA draft guidance on “Co development of two or more unmarketed investigational drugs for use in combination” notes...
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April 20, 2016
During the course of any clinical trial, there are often data which, while collected electronically, are outside of the...
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April 15, 2016
It's critical for biostatistics and data management to be closely aligned and working effectively together. The...
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April 13, 2016
We continue our series of blogs covering the expert presentations from the EAST User Group Meeting. Consultant Claire...
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April 7, 2016
Francois Beckers, Global Head of Biostatistics & Epidemiology at Merck KGaA joined us at the East User Group Meeting in...
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April 5, 2016
Cost of pharmaceutical development and R&D productivity is an ongoing industry concern, consistently discussed in the...
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March 29, 2016
On March 16th and 17th the 5th East User Group Meeting took place in London. This very successful 2 days saw a variety...
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March 23, 2016
“How many statisticians does it take to ensure at least a 50% chance of a disagreement about p-values?” So questions...
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March 11, 2016
There has been increasing interest in multi-arm multi-stage trials with treatment selection and sample size...
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March 8, 2016
Data standardization is critical to ensure successful regulatory submissions. While many sponsors now choose to create...
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March 3, 2016
'The aim of a discussion should not be victory but progress.' This principle, expressed by the French essayist Joseph...
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February 26, 2016
Remember the early days of Electronic Data Capture? Those first systems, which were revolutionary for their time...
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December 3, 2015
On Dec. 12, 2015 Sangeetha Gandepalli, a Technical Lead in Clinical Data Management at Cytel, will speak before SCDM...
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December 1, 2015
Risk based monitoring is a strategic monitoring practice which aims to shine the spotlight on problematic study areas,...
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November 12, 2015
Last week Cytel joined forces with Sanofi/Genzyme to devote a full day of workshops and talks related to modern methods...
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November 10, 2015
Last week Cytel joined forces with Sanofi/Genzyme to devote a full day of workshops and talks related to modern methods...
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November 5, 2015
Oftentimes people perceive a tradeoff between speed and quality. The faster you do something the more likely you are to...
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November 3, 2015
QPP (sometimes called QP2) remains at the heart of model based drug development. Short for Quantitative Pharmacology &...
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October 29, 2015
A common challenge of working with small sample sizes is determining proper bias correction methods when evaluating a...
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October 27, 2015
Here at Cytel we have enjoyed following the debates on the p-value controversy currently taking place on the ASA...
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October 19, 2015
It is often necessary to pool safety data from late phase studies, in preparation for regulatory submission. Some of...
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October 15, 2015
The method for dose-response modeling that is widely called MCPMod allows a sponsor to measure the likelihood that...
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October 13, 2015
In honor of World Obesity Day (celebrated on Oct. 11 2015) here is an American Heart Association Statistical Primer on...
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October 8, 2015
A recent American Statistical Association conference featured a town hall meeting to discuss the role of the...
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October 5, 2015
One consideration every sponsor of a biomarker-stratified confirmatory trial must take into account, is whether to...
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October 1, 2015
This week marks the sixth annual American Conference on Pharmacometrics, held this year in Crystal City, VA. Situated...
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September 29, 2015
The Head of the DIA’s Adaptive Design Working Group Asks Us to Consider 5 ‘Soft-Skills’ All Effective Statisticians...
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September 24, 2015
Earlier this week, Patti Arsenault, Cytel’s Global Head of Clinical Data Management, sat on an SCDM panel with members...
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September 17, 2015
Most people familiar with adaptive clinical trial designs are familiar with those statistical designs that reject the...
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September 4, 2015
Our Client's Challenge: Can knowledge of the relationship between biomarkers and clinical endpoints help us to optimize...
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September 1, 2015
If you’re in the practice of conducting early phase clinical trials, you’ve probably heard that modern trial designs...
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August 13, 2015
Full service or specialized? Full service or specialized? For many looking to hire a CRO, the answer is obvious....
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August 10, 2015
When approaching a Phase 3 clinical trial, the need to ‘de-risk’ the massive investment often leads sponsors on a quest...
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July 27, 2015
We were saddened to learn earlier this year, of the passing of Professor David Sackett. Widely recognized as the father...
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July 21, 2015
MCP-Mod methodology for dose-ranging clinical trials has been gaining popularity since the 2013 publication of the...
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July 14, 2015
When conducting Maximum Likelihood Estimation, it is assumed that the maximum likelihood estimate follows a normal...
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June 26, 2015
Powering a trial for superiority can be financially risky. In some instances it may also prove unnecessary.
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June 25, 2015
When conducting a clinical trial with small or sparse data sets, statistical methods meant for large sample sizes may...
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June 18, 2015
In August 2006 AstraZeneca completed the ARISE trial, which aimed to determine whether AGI-1067 was effective in...
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June 11, 2015
When the FDA first began to require pharmaceuticals to perform cardiovascular outcome trials to establish the safety of...
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June 5, 2015
Not long ago, one of our clients submitted Phase 2 and Phase 3 data for a new rare disease drug which had received...
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June 4, 2015
Two insightful papers from Applied Clinical Trials should be of interest to many clinical trial planners. The first by...
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May 28, 2015
Risks in drug development range from taking the wrong drugs forward to Phase 3 to investing in a drug development...
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May 20, 2015
Seamless adaptive clinical trials have gained popularity for reducing the projected time it takes to complete the...
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May 15, 2015
Imagine that it’s been three years since the completion of a trial, and that suddenly a regulatory body calls into...
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May 14, 2015
Ten years ago, in May 2005, world-renowned biostatistician Marvin Zelen was asked to deliver a keynote address before...
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April 30, 2015
Adaptive financing (not to be confused with adaptive licensing) explores how biotechs, pharmaceuticals and potential...
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April 23, 2015
Last week the Cytel Blog discussed the benefits of using the Adaptive Maximizing Design [AM Design] for dose-finding...
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April 21, 2015
“We shouldn’t use an adaptive design, our sample size is too small.” Most clinical trial planners have heard this line...
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April 16, 2015
When testing certain types of new drugs it is known in advance that the adverse side-effects of the medication will...
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April 13, 2015
Cytel has published a new whitepaper on Monte Carlo Simulations for Patient Recruitment, which illustrates how a...
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April 9, 2015
Last year. Nature Reviews Drug Discovery asked the FDA’s Tatiana Prowell (Hematology & Oncology Products Division)...
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April 2, 2015
Midway through a trial is a terrible time to realize that you need a new strategy to complete the study. Sadly, it is...
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March 27, 2015
We have often said that one of the greatest benefits of an adaptive clinical trial is the flexibility it affords for...
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March 26, 2015
Last year Sunesis completed the VALOR trial, the first clinical study to make use of the groundbreaking promising zone...
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March 20, 2015
Sometimes a new candidate drug for a pediatric study has already been tested on adults for safety and efficacy. We know...
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March 19, 2015
A well-timed interim analysis can generally supply added benefits to the operational and administrative aspects of a...
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March 12, 2015
Recently, we published an interview with Chris Conklin, the Director of the Center for Feasibility Excellence at...
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March 10, 2015
Most of us are primed to think about the design of adaptive clinical trials as a narrow set of techniques applied to a...
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March 5, 2015
The Mehta-Pocock promising zone is often used to carry out unblinded sample size re-estimation during interim analysis....
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February 26, 2015
Cytel President and co-founder Cyrus Mehta has co-authored a paper on Infantile Hemangioma, recently published in the...
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February 17, 2015
21st Century Cures (also called Cures2015) is a bipartisan initiative undertaken by the Committee on Energy and...
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February 12, 2015
Data driven decision-making can ensure that every feasibility team achieves its enrollment milestones. By transforming...
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February 10, 2015
Cardiovascular outcome trials (CVOTs) have earned the reputation of being the untamable behemoths of the clinical...
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February 5, 2015
Every clinical trial requires some manner of trial forecasting, normally for feasibility and patient enrollment....
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February 3, 2015
A new publication co-authored by Cytel Co-Founder and President Cyrus Mehta considers a range of clinical development...
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January 29, 2015
February 2015 marks the five year anniversary of the FDA’s Guidance on Adaptive Design Clinical Trials for Drug and...
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January 27, 2015
Last week we released an infographic on why Phase 3 trials fail. The numbers, while eye-opening, did not capture a...
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January 22, 2015
The Journal of the American Medical Association recently published an article entitled ‘The Anatomy of Medical...
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January 20, 2015
According to a recent Cytel Whitepaper on Adaptive Clinical Trials, 50% of Phase 3 trials eventually fail. This new...
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January 16, 2015
Adaptive designs are thought to be the new paradigm in drug development, allowing statisticians and trial designers to...
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January 13, 2015
Janus was the Roman God of transitions, a deity with two faces, one looking towards the past and the other the future....
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December 18, 2014
Earlier this week, we at Cytel enjoyed a riveting in-house discussion on the uses of Bayesian decision rules for...
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December 16, 2014
Richard Branson once wrote: “I have always valued capability over expertise. While you may need to hire specialists for...
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December 11, 2014
A common framework for the clinical development of vaccines involves the study of several candidate compounds in Phase...
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December 9, 2014
When planning a conventional trial, one can anticipate the drug supply necessary for the trial by determining how the...
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December 4, 2014
Fulyzaq® from Napo/Salix was the first drug ever to be approved using an adaptive two-stage "seamless" clinical trial...
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December 2, 2014
During a recent DIA webinar on reinventing the clinical trial, Laurie Halloran (President of the Halloran Consulting...
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November 18, 2014
Statisticians and scientists at Novartis have been at the forefront of developing a new method in early phase oncology...
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November 17, 2014
Outstanding Thought Leader, Scientist and Humanitarian, Passes away at Age 87 It is with immense sadness that we...
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November 12, 2014
Clinical utility functions provide Phase 2 trial sponsors with an intuitive metric by which to measure the quality of a...
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November 6, 2014
Professor LJ Wei holds that rules are for lawyers, not (necessarily) clinicians. When designing modern clinical trials,...
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November 4, 2014
A key stage of exploratory drug development is implementing a proof-of-concept study to demonstrate the safety of a...
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October 30, 2014
During last week’s East Users Group Meeting, Michael Proschan of the NIH and NIAID, gave a presentation on ‘Blinded...
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October 28, 2014
Phase 1 oncology trials typically use either rule-based methods or model-based methods to determine the most acceptable...
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October 21, 2014
Every year, the East Users Group Meeting brings together notable experts from industry and academia to discuss the...
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October 14, 2014
We are often asked how statistical consultants can add value to the clinical development process. What do they...
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October 7, 2014
Guest blogger Laurie Halloran is the President and CEO of Halloran Consulting Group, a management consulting firm for...
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October 2, 2014
Sofia S. Villar is a member of the DART (Design and Analysis of Randomised Trials) group at the MRC Biostatistics Unit...
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September 25, 2014
A few weeks ago, we posted a synopsis of an event held at ISCB Vienna in which statisticians from Cytel, SAS and Stata...
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September 23, 2014
If you're a company considering an adaptive trial for the first time, you probably have many questions. One of our...
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September 18, 2014
When designing clinical trials, many trial designers are advised to keep the trial simple. Prima facie, the keep it...
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September 11, 2014
According to a recent Impact Report from the Tufts Center for the Study of Drug Development, 21% of active clinical...
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September 4, 2014
Imagine if we were to count the number of possible reasons that investigators might have for monitoring a biomarker...
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September 2, 2014
As more clinical trials make use of adaptive designs, investors have come to realize that high quality trial designs...
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August 26, 2014
During an invited speakers session at the lnternational Society for Clinical Biostatistics, Cytel VP Yannis Jemiai was...
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August 21, 2014
Use of the continual reassessment method (CRM) is safe, efficient, and flexible, according to a comprehensive review of...
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August 14, 2014
Cytel statisticians are looking foward to attending the Conference of the International Society for Clinical...
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August 12, 2014
Beyond Wild Horses: Developing Innovation at Cytel "Horse-and-pony" by arjecahn on flickr. -...
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August 5, 2014
Cytel CTO Nitin Patel, recently sat down with ECHOES (a magazine for statistics in clinical trials) to discuss his...
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July 31, 2014
Statisticians at Cytel are staunch advocates of the use of Bayesian methods in clinical trials. This summer's Joint...
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July 29, 2014
Adaptive designs are the unsurprising hot topic of this year’s Joint Statistical Meeting, which features over one...
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July 24, 2014
This is the third post in a three part series in which we consider (i) improvements to trial quality that result from...
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July 22, 2014
PROCYSBI, the first drug to receive FDA approval after following an adaptive population re-assessment design, was one...
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July 17, 2014
In anticipation of Cyrus Mehta’s webinar next week on new predictive analytics tools for trial forecasting, we thought...
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July 15, 2014
Do you design or analyze Phase 1 dose escalation trials? Have you considered methods other than 3+3? This new Cytel...
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July 10, 2014
Complexities with identifying suitable test populations in oncology studies contribute significantly to the 60%...
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July 8, 2014
The above graphic is from Cyrus Mehta's slides on 'Adaptive Population Enrichment for Oncology Trials with Time to...
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July 1, 2014
A recent Cytel Seminar on Adaptive Statistical Designs featured a talk by Michael Elashoff (Patient Profiles) on...
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June 26, 2014
The rise of biomarker based treatments in oncology has meant a reconceptualization of what constitutes a particular...
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June 10, 2014
The FDA’s Tatiana Prowell (Breast Cancer Scientific Lead in the Office of Hematology & Oncology Products) recently gave...
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June 5, 2014
Charles Liu, PhD, Cytel Statistician and Product Manager In the US, cancer is the most common cause of death after...
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June 3, 2014
This is the second post in a three part series in which we consider (i) improvements to trial quality that result from...
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May 29, 2014
Cytel has taken the initiative to train the next generation of clinical programmers through its innovative Clinnical...
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May 22, 2014
This is the first of a three part post in which we will consider (i) improvements to trial quality that result from...
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May 19, 2014
Pantelis Vlachos, PhD, is a Director at Cytel Consulting. He works with a team of experts who regularly assist clinical...
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May 13, 2014
The VALOR trial recently applied a promising zone design to a Phase 3 evaluation of Vosaroxin, a candidate for the...
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May 8, 2014
( Editor's note: This post has been refreshed in December 2016) Model based algorithms for Phase I dose-escalation have...
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May 5, 2014
A new JAMA study on discontinued randomized trials in Switzerland, Germany and Canada, reports that poor recruitment...
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April 30, 2014
For the second installment of our StatXact 25th Anniversary Retrospective Series, Professor Joan Hilton (UC San...
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April 24, 2014
Here at Cytel we firmly believe that if you don’t get the design of a clinical program right, then nothing else...
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April 21, 2014
The core methodological problem that would eventually spur the development of Cytel’s StatXact software was first posed...
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