March 24, 2023
Last week, we featured our final Winter Weekend Read, the last in a series designed to showcase our complimentary..
Read article
March 21, 2023
One of the lesser-known complications associated with Multiple Sclerosis is a higher risk of serious infections (SIs)...
Read article
March 17, 2023
Smaller clinical trials can be optimized in significant ways using simulation-guided design. A small biotech studying..
Read article
March 13, 2023
Many industries have long since adopted the practice of modeling and simulating experimental scenarios. And despite..
Read article
March 8, 2023
Real-world data has been increasingly used to answer questions related to the course, prognosis, and treatment of..
Read article
March 7, 2023
Grammati Sarri was recently interviewed by Inside Precision Medicine for “Improving Health Equity Starts with..
Read article
March 3, 2023
The speed of scientific discovery has been outpacing the ability of researchers to accumulate and integrate constantly..
Read article
February 24, 2023
Last week, Cytel Director & Research Principal Louis Dron discussed new FDA guidance on the design and conduct of..
Read article
February 22, 2023
Simulation-guided design is quickly becoming a novel feature of modern drug development. Its foundational promise is to..
Read article
February 14, 2023
The U.S. FDA has recently provided specific guidance[i] on the design and conduct of trials incorporating an external..
Read article
February 9, 2023
Those familiar with simulation-guided design (SGD) know that it can be used for a wealth of clinical trial options:..
Read article
February 8, 2023
Over the past years, probably the entire last decade, there have been several discussions on how to handle multiple..
Read article
February 3, 2023
For clinical development and research and development teams, the Pareto Frontier can perform two functions. Let’s take..
Read article
January 31, 2023
Asthma affects more than 235 million people worldwide, and due to lacking effective implementation of clinical..
Read article
January 27, 2023
Should your clinical trial be adaptive? Trials that include a prospectively planned modification based on an interim..
Read article
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..
Read article
January 23, 2023
Ever since the first immune checkpoint inhibitor was approved for market nearly twelve years ago, the industry has..
Read article
January 20, 2023
A small biotech’s conventional carcinoma trial design was too expensive to implement and did not offer the opportunity..
Read article
January 17, 2023
When it comes to rare diseases, a handful of major challenges to drug development arise. Bayesians strategies have..
Read article
January 13, 2023
Bayesian methods, with their ability to facilitate flexibility and learning, are often associated with early-phase..
Read article
January 12, 2023
Statistical methods have long been fundamental to drug development, and advancements in the last few decades in..
Read article
January 6, 2023
You may have heard that our clinical trial strategy platform Solara® won the Fierce Life Sciences award for Technology..
Read article
January 4, 2023
Returning to Cytel after the winter holidays, I am excited to begin a year that will likely prove memorable for both..
Read article
December 29, 2022
Perspectives on Enquiry and Evidence explores a wide variety of topics within clinical trial design and data science in..
Read article
December 27, 2022
Bayesian methods have been playing a key role in transforming clinical research, providing a variety of new..
Read article
December 21, 2022
Perspectives on Enquiry and Evidence features two recurring interview series: Our new Industry Voices series, in which..
Read article
December 19, 2022
Adaptive trial designs – that is, trials that include a prospectively planned modification based on an interim analysis..
Read article
December 16, 2022
Bayesian methods have been playing a key role in transforming clinical research, and Bayesian topics are frequently..
Read article
December 14, 2022
When evaluating the efficacy of a candidate investigational therapy, a standard clinical trial paradigm is to conduct a..
Read article
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..
Read article
December 6, 2022
In this edition of the Career Perspectives series, I spoke with Veronica Chan, Principal Clinical Data Manager at..
Read article
December 2, 2022
For 35 years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to..
Read article
November 29, 2022
Bayesian methods have continuously played a key role in transforming clinical research in therapeutic areas such as..
Read article
November 18, 2022
In the following interview, Dr. Parvin Fardipour, Quantitative Strategies & Data Science, sits down with Heather..
Read article
November 14, 2022
When conducting network meta-analysis (NMA) – that is, a technique that involves comparing multiple treatments..
Read article
November 9, 2022
In this edition of the Career Perspectives series, I interview Malte Stein, Senior Biostatistician. Malte owned the..
Read article
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),..
Read article
November 3, 2022
Cytel will be represented at over 60 presentations at ISPOR Europe 2022, with more issue panels and workshops than any..
Read article
November 2, 2022
Pharmaceutical research in oncology is increasingly focused on the development of therapies targeted at newly..
Read article
October 28, 2022
Integrating the “pressure testing” of clinical trial designs into the process of creating a strong clinical trial..
Read article
October 24, 2022
On the occasion of Cytel’s 35th anniversary, co-founder Professor Cyrus Mehta sits down with Dr. Esha Senchaudhuri to..
Read article
October 18, 2022
On the occasion of Cytel’s 35th anniversary, co-founder Professor Nitin Patel sits down with Dr. Esha Senchaudhuri to..
Read article
October 14, 2022
In this edition of the Career Perspectives series, I interview Nicolas Rouillé, Senior Director, Statistical..
Read article
October 13, 2022
ISPOR Europe, the leading global conference for health economics and outcomes research (HEOR) and real-world evidence..
Read article
October 11, 2022
On the occasion of Cytel’s 35th anniversary, our CEO Joshua Schultz sits down with Dr. Esha Senchaudhuri to discuss the..
Read article
October 5, 2022
Master protocols and platform clinical trials have become an innovative and efficient approach to testing multiple..
Read article
October 4, 2022
Integrated Nested Laplacian Approximations (or INLA) are now starting to be used by statisticians as a key tool for..
Read article
October 3, 2022
The wider availability of electronic health data, medical registries, and even larger proprietary datasets means that..
Read article
September 28, 2022
The landscape of drug development has changed dramatically over the last few decades, and effective statistical leaders..
Read article
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)
Read article
September 23, 2022
Adaptive trial designs – that is, trials that include a prospectively planned modification based on an interim analysis..
Read article
September 16, 2022
In the first part of this article, I raised awareness of the availability of additional FDA guidances containing CDISC..
Read article
September 15, 2022
On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022, which includes U.S. drug..
Read article
September 12, 2022
In clinical trials, patient enrollment is often staggered, with data collected sequentially. When designing a clinical..
Read article
September 9, 2022
A new trend has emerged over the last decade that has changed the way many clinical trials are conducted. Unlike..
Read article
September 8, 2022
The American Statistical Association Biopharmaceutical Section, in cooperation with the FDA Statistical Association,..
Read article
September 2, 2022
Last week, we featured our final Summer Weekend Read, the last in a series designed to showcase some of our most recent..
Read article
August 30, 2022
Many thanks to Kyle Wathen and Behnam Sharif for their input on this post.
Read article
August 26, 2022
To continue our Summer Weekend Reads series, Cytel presents “Discover the Value of an Optimized Clinical Data Strategy”..
Read article
August 25, 2022
The International Society for Pharmacoepidemiology is hosting its “ICPE 2022: Advancing Pharmacoepidemiology and..
Read article
August 18, 2022
The American Statistical Association’s annual Joint Statistical Meeting (JSM) gathered over 6,500 attendees from 52..
Read article
August 4, 2022
In this edition of the Career Perspectives series, I interview Allison Luccock, Director of Business Operations for..
Read article
August 3, 2022
A number of late-phase clinical trial sponsors remain hesitant to employ Bayesian approaches in confirmatory settings,..
Read article
July 28, 2022
When new treatments are compared with existing therapies in clinical care, population-adjustment techniques need to..
Read article
July 27, 2022
Written by Jing Ping Yeo and Charles Warne Adaptive designs are studies that “include a prospectively planned..
Read article
July 26, 2022
To watch this webinar and others from this introductory series, click the link below. The ability to draw on..
Read article
July 20, 2022
When performing indirect treatment comparisons, effect modification can create complexities in the event of high..
Read article
July 13, 2022
Many thanks to Grammati Sarri and Michael Groff for their comments in developing this blog. An indirect treatment..
Read article
July 12, 2022
Thanks to Dr. Kyle Wathen for comments on this blog. The increasing use of platform trials for the testing of a wide..
Read article
July 7, 2022
The gold standard for assessing the efficacy for a medicine continues to be RCTs, however, for many reasons (disease..
Read article
June 29, 2022
How can we build an efficient statistical protocol for a clinical trial, if we do not know the therapies that will be..
Read article
June 28, 2022
Founded in 1987 by Cyrus Mehta and Nitin Patel, research scientists at Harvard University and MIT respectively and..
Read article
June 22, 2022
It can be difficult to estimate just how much time and data you need to address the multitude of considerations that..
Read article
June 15, 2022
For years CDISC data standards implementers have struggled to find good implementation examples and use cases beside..
Read article
June 14, 2022
Suppose you had to choose six clinical trials intended for registration with regulatory agencies, only six, to explain..
Read article
June 13, 2022
The International COVID-19 Data Alliance (ICODA) was formed to address the challenge of generating rapid and rigorous..
Read article
June 8, 2022
Clinical researchers, seeking to understand the statistical benefits of a common Phase 2 oncology design, now have a..
Read article
June 7, 2022
In most instances of blinded sample size re-estimation, the timing of the interim analysis that determines whether the..
Read article
June 6, 2022
The award-winning TOGETHER Trial was designed with the vision of ensuring that COVID-19 therapies are both effective..
Read article
June 2, 2022
How can clinicians at the forefront of modern clinical trials and statisticians at the forefront of advanced..
Read article
May 31, 2022
The TOGETHER Trial for COVID-19 therapies, designed by clinical trial specialists at Cytel won the Society for Clinical..
Read article
May 27, 2022
When submitting systematic literature reviews to a Health Technology Assessment authority, high volumes of research..
Read article
May 26, 2022
When constructing estimands a key question that arises is how to handle intercurrent events and missing data. In a..
Read article
May 24, 2022
Traditionally, clinical trials are expensive, long in duration, and have low success rate. But with the advent of rich..
Read article
May 17, 2022
Early in the pandemic, it became clear that many of the COVID-19 therapies being tested in wealthier nations, were not..
Read article
May 16, 2022
A combination of industry and policy forces have recently changed the shape of Australia’s R&D sector, making it a..
Read article
May 12, 2022
Synthetic control arm (SCA) methods are statistical methods that are seeing rapidly increasing use in comparative..
Read article
May 5, 2022
While randomized control trials remain the industry gold-standard for regulatory and reimbursement submissions, there..
Read article
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..
Read article
May 3, 2022
In 2005, Pfizer launched a Phase 1 trial for the kinase inhibitor crizotinib. Six years later, it was approved, thanks..
Read article
April 29, 2022
At ISPOR US 2022, Cytel’s HEOR & RWE experts will be contributing to a range of Issue Panels, In-person Podium..
Read article
April 27, 2022
New medicines and devices under development live and die on the strength of their clinical data. An asset’s journey is..
Read article
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..
Read article
April 22, 2022
This past decade has undoubtedly witnessed an increase in the number of single arm trials submitted to HTA bodies...
Read article
April 21, 2022
Sophisticated Bayesian Methods are gaining a lot of traction as they bring flexibility and speed to clinical trial..
Read article
April 13, 2022
The Life Sciences landscape has seen an impactful digital evolution in the past two years. The pandemic has accelerated..
Read article
April 12, 2022
In this edition of the Career Perspectives series, I interview Charles Warne, Associate Director of Biostatistics at..
Read article
April 8, 2022
The planning and optimization of a clinical trial is beset by uncertainties: knowledge of treatment effects, the..
Read article
April 7, 2022
Randomized control trials (RCTs) are the gold standard for estimating the efficacy of a treatment. They allow us to..
Read article
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..
Read article
April 1, 2022
At the end of every year, scientists from across Cytel’s business units are nominated for Cytel’s Spotlight Awards,..
Read article
March 23, 2022
For over a decade, the number one reason cited for trial discontinuity has been challenges associated with recruitment..
Read article
March 18, 2022
Real world evidence (RWE) provides a large and growing source of insights into drug uptake and safety. It is..
Read article
March 11, 2022
Every year, sponsors hesitating to use a complex innovative clinical trial design routinely miss opportunities to..
Read article
March 8, 2022
The issue of delayed treatment effects in immuno-oncology was demonstrated during a FDA-Industry sponsored workshop..
Read article
February 22, 2022
When determining the best possible statistical design for a particular trial, large pharmaceuticals and small biotechs..
Read article
February 18, 2022
Data is the most crucial asset of any clinical trial and hence, sponsors cannot jeopardize collecting clean..
Read article
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..
Read article
February 15, 2022
As the use of advanced and innovative clinical trial designs continue to rise, sponsors often wonder which estimation..
Read article
February 11, 2022
Adopting data standards such as CDISC in the early phase of clinical drug development contributes to the consolidation..
Read article
February 9, 2022
Data is the cornerstone of any clinical trial and is used to ultimately drive the decision-making process related to..
Read article
February 4, 2022
The ability to conduct data-driven and quantitatively rigorous feasibility studies, is often key to successful trial..
Read article
February 2, 2022
For nearly ten years, suboptimal trial enrollment has been cited as a primary cause of clinical trial discontinuation...
Read article
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” –..
Read article
January 26, 2022
In this edition of the Career Perspectives series, I interview Jessica Bhoyroo, Cytel Clinical Data Manager based in..
Read article
January 25, 2022
In this blog, I share some experiences we recently had during an FDA submission Cytel performed for a sponsor after..
Read article
January 21, 2022
For our first Winter Weekend Read, Cytel presents How to Use and Interpret the Results of a Platform Trial, a JAMA..
Read article
January 20, 2022
Limited patient populations resulting in small study sample sizes is a difficulty associated with the development of..
Read article
January 19, 2022
The past two years have been transformative for Cytel. Most notably, the global COVID-19 pandemic unleashed an..
Read article
December 23, 2021
Cytel blogs bring you debate and discussion of the newest trends in statistics and quantitative strategy. In 2021, our..
Read article
December 20, 2021
The promising zone design is an adaptive design which allows for sample size re-estimation based on the results of an..
Read article
December 15, 2021
Recently, on November 29 I received an email from CDISC announcing an important update for both SDTM and ADaM CDISC..
Read article
December 14, 2021
In traditional clinical trial design, the sample size is often determined to detect the target treatment effect with..
Read article
December 8, 2021
Despite the debate in the scientific community on adaptive sample size reassessment (SSR), noteworthy developments have..
Read article
December 7, 2021
Sponsors bringing a successful new product to market have to overcome two hurdles: submission and reimbursement. For..
Read article
November 30, 2021
The FDA “Real-Time Oncology Review (RTOR)”[1] is an “FDA project started in 2018 to facilitate earlier submission of..
Read article
November 30, 2021
The aim of any clinical research is to detect the actual difference in treatment effect between two groups (power) and..
Read article
November 23, 2021
A randomized clinical trial (RCT) is the gold standard approach to demonstrate the efficacy and safety of novel..
Read article
November 17, 2021
Traditionally, the teams responsible for clinical development and regulatory submissions do not consult the market..
Read article
November 15, 2021
Since its first publication ten years ago, Cyrus Mehta and Stuart Pocock’s Promising Zone Design for sample size..
Read article
November 11, 2021
The value of Real World Evidence (RWE) is well known to many stakeholders, but its full potential for market access and..
Read article
November 10, 2021
There are many reasons why traditional approaches to designing a clinical study are generally suboptimal and do not..
Read article
November 8, 2021
Ten years ago Cytel co-founder Professor Cyrus Mehta and Professor Stuart Pocock of the London School of Hygiene and..
Read article
November 4, 2021
The prominent European conference for Health Economics and Outcomes Research (HEOR), ISPOR Europe 2021, is around the..
Read article
November 2, 2021
A good clinical study design performs well not only under the ideal target scenario. Statisticians should be able to..
Read article
October 29, 2021
A platform trial, a type of Master Protocol, is an experimental infrastructure to evaluate multiple treatments and/or..
Read article
October 27, 2021
A staged investment strategy aligns R&D decisions and financial planning with the interim looks of a clinical trial. If..
Read article
October 22, 2021
Currently, there are many treatment options for Cancer such as, Immunotherapy, Radiation Therapy, Chemotherapy etc. If..
Read article
October 21, 2021
A number of methods currently exist to measure non-adherence and non-persistence of medical therapies, for improved..
Read article
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..
Read article
October 15, 2021
Almost 3000 registered trials were performed in COVID-19 and a majority of them have been small and likely..
Read article
October 14, 2021
When choosing the optimal clinical trial design for a given study, sponsors face critical questions like choice of..
Read article
October 7, 2021
‘Drugs do not work in patients who do not take them,’ said former surgeon general C. Everett Koop. Unfortunately, the..
Read article
October 6, 2021
Master Protocols are advanced and innovative clinical trial designs that can evaluate multiple therapies and disease..
Read article
October 5, 2021
Traceability is crucial in all steps of clinical data handling, from data collection to final analysis. The importance..
Read article
October 1, 2021
The COVID-19 pandemic elevated the challenge of designing and executing clinical trials within a substantially..
Read article
September 30, 2021
A complex methodological issue which arises in the production of real-world evidence involves the degree to which..
Read article
September 29, 2021
While there is a plethora of rare diseases, some 7000 diseases and counting, one needs to consider the statutory..
Read article
September 24, 2021
We may be familiar with adaptive designs, but their complexity has made them difficult to implement and their benefits..
Read article
September 23, 2021
A complex methodological issue which arises in the production of real-world evidence involves the degree to which..
Read article
September 21, 2021
Earlier this summer, we published a series of articles on the need to utilize weighting and prioritization tools in the..
Read article
September 15, 2021
There is recognized heterogeneity within any given tumor‐type from patient to patient (inter‐patient heterogeneity),..
Read article
September 14, 2021
Alyssa Biller is a Senior Solutions Consultant at Cytel and currently plays a primary role in onboarding customers for..
Read article
September 8, 2021
A key decision in the design of clinical trials in oncology involves whether to select progression free survival (PFS)..
Read article
August 31, 2021
For years, I have been telling the recruiters at Cytel to be wary of candidates claiming to have a CDISC Certification..
Read article
August 20, 2021
In clinical research, decision makers need to choose among different courses of action every day. Whether it is..
Read article
August 18, 2021
During the design of a clinical trial, many biotechs want to substantially reduce the risk of a good new therapy being..
Read article
August 13, 2021
With the cloud computing power that we have today, we can run simulation of 1000s of designs with each design..
Read article
August 10, 2021
A few weeks ago I wrote about new research conducted by Cytel statisticians, on the challenge of conducting..
Read article
August 9, 2021
Recently we discussed examining clinical development through a Bayesian lens, in honor of Cytel co-founder Nitin Patel..
Read article
August 5, 2021
It is important to compare competing interventions to determine value of medicines, both from clinical and societal..
Read article
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..
Read article
July 28, 2021
“We found an optimal design in hours that might have taken months to find using standard methods,” reflected Fabien..
Read article
July 27, 2021
Program and portfolio optimization creates a framework throughout the course of the clinical development journey, that..
Read article
July 22, 2021
Earlier this year, Cytel founder Cyrus Mehta observed that clinical trial design is often treated like an art rather..
Read article
July 21, 2021
Conducting a transparent, targeted and robust benefit-risk assessment of a new drug or product is one of the most..
Read article
July 20, 2021
Anil Golla is Vice President, Functional Service Provision (FSP) at Cytel. After 17 years of working at pharmaceutical..
Read article
July 14, 2021
For decades, statisticians have cultivated methods to optimize and de-risk clinical trials for strong regulatory..
Read article
July 12, 2021
Medical researchers and public health experts are becoming more reliant on meta-analyses to capture in summary form,..
Read article
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..
Read article
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.,..
Read article
July 1, 2021
Synthetic control arms (SCAs) are best suited for situations when a single arm trial is run in a patient population..
Read article
June 30, 2021
When Cyrus Mehta introduced the Promising Zone Design over a decade ago, the new statistical method not only..
Read article
June 25, 2021
The main challenge associated with the development of therapies for rare diseases is typically the small study sample..
Read article
June 24, 2021
Synthetic control arms (SCAs) leverage real world data from various sources or evaluations of historical clinical data..
Read article
June 23, 2021
Much of the discussion about clinical trial design considers methods to optimize performance characteristics and..
Read article
June 18, 2021
Next week’s PSI Conference will feature Dr. Yannis Jemiai speaking on the use of Scoring Functions in the re-imagined..
Read article
June 17, 2021
In Part 2 of this four-part blog series, we bust another myth surrounding synthetic control arms (SCAs) used in..
Read article
June 15, 2021
Ten years ago, a seminal paper published by Cytel Founder Cyrus Mehta, introduced the Promising Zone Design to..
Read article
June 14, 2021
ACDM’s (Association for Clinical Data Management) eDigital data management expert group (DMEG) focuses on driving..
Read article
June 10, 2021
Over the past decade, single arm trials have emerged as an accepted way of assessing a new treatment intervention...
Read article
June 9, 2021
When selecting clinical trial designs, how many design options should a sponsor explore? Would a sponsor feel more..
Read article
June 4, 2021
Bayesian methods have been playing a key role in transforming clinical research in therapeutic areas such as oncology..
Read article
June 3, 2021
Bayesian methods allow for the incorporation of prior knowledge, in terms of either expert opinion from clinicians or..
Read article
June 2, 2021
For many decades the Pareto Frontier has been employed by actors in the private sector to evaluate and understand the..
Read article
May 28, 2021
Advancements in biomarkers and momentum in precision medicine has paved the foundation for complex studies like basket..
Read article
May 21, 2021
Most of us are familiar with the concept of platform clinical trials as they have gained popularity in the recent..
Read article
May 20, 2021
As more payers and HTA agencies turn to real world data to compare the effectiveness of various treatment effects, two..
Read article
May 19, 2021
Clinical trial sponsors are more likely than ever to use the power of simulation and forecasting to evaluate the..
Read article