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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