
Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.

September 25, 2023
As the pressure to reduce timelines rises across the industry, independent data monitoring committees (IDMCs) — which...
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September 22, 2023
Myth Busting: Master Protocol Edition
Interest and appetite for master protocols is growing as sponsors consider opportunities in various therapeutic areas...
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September 20, 2023
FSP Behind the Scenes with Anwaya Joshi, Programming Senior Team Lead
Cytel’s Functional Service Provision (FSP) teams work on exciting projects with biotech and pharmaceutical companies as...
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September 18, 2023
Cytel Publishes Inaugural Sustainability Report
With the ongoing changes inherent in the life sciences industry comes heightened expectations for companies to take...
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September 13, 2023
Setting Expectations for Formal Interim Analyses with Independent Data Monitoring Committees
Independent data monitoring committees (IDMCs) review ongoing clinical trial data to make recommendations regarding...
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September 11, 2023
How to Ask the Right Questions at an Authority Meeting
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
Synthetic Control Arms: Leveraging Real-World Data for Comparison in Single-Arm Trials
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
Key Considerations in Planning Your Clinical Data Strategy
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
FSP Behind the Scenes with Jeff Thompson, R Senior Statistical Programmer
Cytel’s Functional Service Provision (FSP) teams work on exciting projects with biotech and pharmaceutical companies as...
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August 28, 2023
How to Create and Optimize a Clinical Development Plan
A clinical development plan — a comprehensive strategy for developing an investigational product through regulatory...
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August 25, 2023
Preparing and Concluding Your FDA Data Submission, and More Insights on Data Submission and Data Integration
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
Adaptive Multi-Arm Multi-Stage Designs: A Comparison of Methods
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 Advantages of Forecasting Enrollment with a Model-Based Approach
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
The Evolution of Open-Source Initiatives and New Standards Development for the Data Submission of the Future
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
Demonstrating Value in Real Time with Living Models for Systematic Literature Reviews
Systematic literature reviews are essential for proving product value to health authorities, clinicians, and payers,...
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August 9, 2023
Standards and Open Source Hand-in-Hand: Leveraging Automation to Expedite Drug Market Request Review Process
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
Bayesian Methods for Strategic Clinical Trial Design
“There is always the risk that interim analyses might occur after the Sufficient Information Threshold has been...
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August 1, 2023
Dynamic Bayesian Borrowing to Bolster Limited Sample Sizes in Rare Indications
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
Embracing AI and ML in Medical Devices: FDA’s Total Product Lifecycle-Based Regulatory Framework
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
Real-Life Data-Sharing and EU Joint Clinical Assessments: Is Closing this Chasm a Mission Impossible?
Written by Grammati Sarri, David Smalbrugge, Andreas Freitag, and Evie Merinopoulou The vision of a single, centralized...
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June 20, 2023
New FDA Guidelines on Pediatric Studies and Potential Effects on Opportunities for Market Exclusivity
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
Embracing Innovation: Exploring the Design of Umbrella and Basket Trials
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
Maximizing Study Momentum: A Case Study in Accelerated DMC Safety Report Creation through IDMC Solutions
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
A Spotlight on FSP Programming
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
Maria Lundberg on a Holistic Approach to Therapeutics Development
Cytel recently announced the launch of its Therapeutics Development Team, bringing together quantitative,...
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June 2, 2023
Presenting Clinical Data for Regulatory Submission: A Stats Perspective
Data submissions are very regulated, but every drug and drug development are different. Therefore, the data presented...
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May 24, 2023
It’s Time to Move, Time to Move to Define-XML 2.1
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
New CADTH Guidance on RWE Is Now Available, but Critical Aspects Are Still Missing
By Grammati Sarri, Evie Merinopoulou, Vinusha Kalatharan, and Jason Simeone The Canadian Agency for Drugs and...
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May 10, 2023
FDA Increases Calls for Manufacturers to Ensure Trial Diversity, but Does It Fall Short of Addressing Health Inequalities in Product Development?
The evidence is staggering on the unequal health burdens experienced by specific patient groups defined by ethnic,...
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May 5, 2023
Scott Gaines on the Power of Simulation-Guided Design to Handle Increasingly Complex Clinical Trials
As clinical trials become more complex, simulation-guided design approaches are crucial. For this edition of the...
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May 3, 2023
Reflections on the RCT DUPLICATE Study and Increasing Confidence in Real-World Evidence
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
New Ebook: “The Good Data Doctor on Data Submission and Data Integration”
Regular technical discussions with the FDA play a critical role in ensuring data submission success. These discussions...
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April 25, 2023
How Target Trial Emulation Can Take the Guesswork Out of Comparative Effect Estimates in Medicare Drug Price Negotiation
An interview with Miguel Hernán, Harvard University Kolokotrones Professor of Biostatistics and Epidemiology On March...
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April 24, 2023
APAC Biopharma Industry Insights: Trends, Opportunities, and Challenges
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
CDISC Europe 2023: A Preview
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
Navigating Comparative Effectiveness in the Inflation Reduction Act: Methodological Approaches for Healthcare Challenges
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
Data Challenges (and Solutions) for Externally Controlled Trials
Real-world data and evidence are increasingly being used in health care decisions and publications. However, there are...
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April 11, 2023
Overcoming the Shared Effect Modifier Assumption with Network Meta-Interpolation
Commonly used methods to handle the complexities of effect modification in indirect treatment comparisons (ITCs) often...
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April 5, 2023
Comparative Effectiveness: Methods and Techniques for Better Decision-Making
Health technology assessment (HTA) submissions require cost effectiveness analyses based on comparative effectiveness...
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March 24, 2023
Winter Weekend Read Roundup
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
Retrospective Claims Data Analysis Unlocks Discovery in Multiple Sclerosis Research
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
Optimizing Small Clinical Trials with Simulation-Guided Design: A Case Study
Smaller clinical trials can be optimized in significant ways using simulation-guided design. A small biotech studying...
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March 13, 2023
Industry Voices: Yannis Jemiai on Simulation-Guided Design and the Changing Landscape of Clinical Trial Strategy
Many industries have long since adopted the practice of modeling and simulating experimental scenarios. And despite...
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March 8, 2023
New Linked Database Expands Potential of RWE: A Unique Opportunity for Multiple Sclerosis Research
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
Can RWE Help Restore Decades of Health Inequalities? Yes, and Here’s How
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
Multiple Myeloma Research Benefits from Living Model SLR: A Case Study
The speed of scientific discovery has been outpacing the ability of researchers to accumulate and integrate constantly...
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February 24, 2023
Demystifying Synthetic Control Arms
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 for Biotechs
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
FDA Guidance on the Design and Conduct of Externally Controlled Trials — What to Watch
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
Supercharging Quantitative Decision-Making with Simulation-Guided Trial Design
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
The Facts in the Case of Subject X
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
Focal Points and Monetization: New Uses of Pareto Frontiers in Clinical Development
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
Linked Data Studies: Improving the Way We Do Observational Research in Germany
Asthma affects more than 235 million people worldwide, and due to lacking effective implementation of clinical...
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January 27, 2023
To Adapt or Not to Adapt? A Decision Framework
Should your clinical trial be adaptive? Trials that include a prospectively planned modification based on an interim...
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January 25, 2023
Bayesian Approach in Oncology Trials
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
Design Considerations for Early Phase Trials of Immuno-oncology Drugs
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
Strategic Clinical Trial Design Unlocks Innovative Funding Opportunity
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
Bayesian Strategies in Rare Diseases
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 across the Clinical Development Journey
Bayesian methods, with their ability to facilitate flexibility and learning, are often associated with early-phase...
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January 12, 2023
Why Are There Not More Bayesian Clinical Trials?
Statistical methods have long been fundamental to drug development, and advancements in the last few decades in...
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January 6, 2023
Simulation-Guided Design Is Reshaping Clinical Trial Strategy
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
A Look Ahead for 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 29, 2022
Top Perspectives Articles of 2022
Perspectives on Enquiry and Evidence explores a wide variety of topics within clinical trial design and data science in...
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December 27, 2022
Top Bayesian Topics of 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
Top Interviews of 2022: Industry Voices and Career Perspectives
Perspectives on Enquiry and Evidence features two recurring interview series: Our new Industry Voices series, in which...
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December 19, 2022
Top Adaptive Clinical Trial Topics of 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
Topics in Bayesian Statistical Methods
Bayesian methods have been playing a key role in transforming clinical research, and Bayesian topics are frequently...
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December 14, 2022
Accrual When Starting a Platform Trial vs. in a Stand-Alone Trial
When evaluating the efficacy of a candidate investigational therapy, a standard clinical trial paradigm is to conduct a...
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December 9, 2022
(Re)Integration Dilemma: Integrated Summaries of Safety and Effectiveness
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
Career Perspectives: A Conversation with Veronica Chan
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
Celebrating 35 Years of Innovation and Impact: An Interview Series
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 Adaptive Clinical Trial Designs: INLA vs. MCMC
Bayesian methods have continuously played a key role in transforming clinical research in therapeutic areas such as...
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November 18, 2022
Industry Voices: Dr. Parvin Fardipour on New Horizons in Data Science
In the following interview, Dr. Parvin Fardipour, Quantitative Strategies & Data Science, sits down with Heather...
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November 14, 2022
Network Meta-Interpolation: Effect Modification Adjustment in Network Meta-Analysis Using Subgroup Analyses
When conducting network meta-analysis (NMA) – that is, a technique that involves comparing multiple treatments...
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November 9, 2022
Career Perspectives: A Conversation with Malte Stein
In this edition of the Career Perspectives series, I interview Malte Stein, Senior Biostatistician. Malte owned the...
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November 8, 2022
A Preview of Cytel’s Contributions to PHUSE EU 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 at ISPOR Europe: Two Workshops
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
Bayesian Hierarchical Modelling for Histology-Independent Therapies
Pharmaceutical research in oncology is increasingly focused on the development of therapies targeted at newly...
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October 28, 2022
Measuring Robustness of Clinical Trial Designs with Pressure Tests
Integrating the “pressure testing” of clinical trial designs into the process of creating a strong clinical trial...
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October 24, 2022
Cyrus Mehta on the Founding of Cytel
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
Nitin Patel on 35 Years of Technological Innovation
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
Career Perspectives: A Conversation with Nicolas Rouillé
In this edition of the Career Perspectives series, I interview Nicolas Rouillé, Senior Director, Statistical...
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October 13, 2022
Cytel at ISPOR Europe: Top Presenter of Issue Panels and Workshops
ISPOR Europe, the leading global conference for health economics and outcomes research (HEOR) and real-world evidence...
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October 11, 2022
Joshua Schultz on the Evolution of Cytel
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 5, 2022
Platform Trials, Can they Benefit Animal Studies?
Master protocols and platform clinical trials have become an innovative and efficient approach to testing multiple...
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October 4, 2022
MCMC vs. INLA in Bayesian Adaptive Clinical Trial Designs
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
Bayesian Methods for Historical Borrowing: Conjugate Priors
The wider availability of electronic health data, medical registries, and even larger proprietary datasets means that...
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September 28, 2022
Statistical Leaders and the Future of Drug Development
The landscape of drug development has changed dramatically over the last few decades, and effective statistical leaders...
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September 27, 2022
Data Capture and Data Sharing During the COVID-19 Pandemic
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 Trials at the Mainstream of Drug Development
Adaptive trial designs – that is, trials that include a prospectively planned modification based on an interim analysis...
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September 16, 2022
Raising Awareness for Additional FDA Data Standards Submission Recommendations (Part II)
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
U.S. Drug Pricing Reform: Potential Impact on Pharma HEOR Evidence Generation
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
On Frequentist and Bayesian Sequential Clinical Trial Designs
In clinical trials, patient enrollment is often staggered, with data collected sequentially. When designing a clinical...
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September 9, 2022
Developing Synthetic Control Arms Using Bayesian Models
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
Cytel Present at the ASA Biopharmaceutical Section Regulatory Workshop
The American Statistical Association Biopharmaceutical Section, in cooperation with the FDA Statistical Association,...
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September 2, 2022
Summer Weekend Read Roundup
Last week, we featured our final Summer Weekend Read, the last in a series designed to showcase some of our most recent...
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August 30, 2022
Understanding the Economic Benefits of Platform Trials
Many thanks to Kyle Wathen and Behnam Sharif for their input on this post.
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August 26, 2022
Discover the Value of an Optimized Clinical Data Strategy
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
Cytel Presents at ICPE 2022
The International Society for Pharmacoepidemiology is hosting its “ICPE 2022: Advancing Pharmacoepidemiology and...
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August 18, 2022
Highlights from JSM 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
Interview with Allison Luccock about career perspectives
In this edition of the Career Perspectives series, I interview Allison Luccock, Director of Business Operations for...
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August 3, 2022
The Uses of Bayesian Methods in Late-Phase Clinical Trial Strategy
A number of late-phase clinical trial sponsors remain hesitant to employ Bayesian approaches in confirmatory settings,...
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July 28, 2022
New Directions in Indirect Treatment Comparisons
When new treatments are compared with existing therapies in clinical care, population-adjustment techniques need to...
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July 27, 2022
Adaptive Designs Are Re-Defining Drug Development – Learn What's New
Written by Jing Ping Yeo and Charles Warne Adaptive designs are studies that “include a prospectively planned...
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July 26, 2022
7 Ways RWD Is Transforming Clinical Research
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
The Case for Network Meta-Interpolation to Handle Effect Modifiers in Indirect Treatment Comparisons
When performing indirect treatment comparisons, effect modification can create complexities in the event of high...
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July 13, 2022
5 Steps to Adjust for Effect Modifiers for Treatment Comparisons
Many thanks to Grammati Sarri and Michael Groff for their comments in developing this blog. An indirect treatment...
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July 12, 2022
Strategies for Selecting New Indications for a Platform Trial
Thanks to Dr. Kyle Wathen for comments on this blog. The increasing use of platform trials for the testing of a wide...
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July 7, 2022
Using Quantitative Bias Analysis in Real World Data Strategy
The gold standard for assessing the efficacy for a medicine continues to be RCTs, however, for many reasons (disease...
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June 29, 2022
Platform Trials, Master Protocols, and Challenges in Execution
How can we build an efficient statistical protocol for a clinical trial, if we do not know the therapies that will be...
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June 28, 2022
Career Perspectives: Reflecting at 10 Years in Cytel FSP
Founded in 1987 by Cyrus Mehta and Nitin Patel, research scientists at Harvard University and MIT respectively and...
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June 22, 2022
How to Determine if Your Clinical Trial Has Sufficient Data?
It can be difficult to estimate just how much time and data you need to address the multitude of considerations that...
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June 15, 2022
Raising the Awareness for Additional FDA Data Submission Recommendations (Part I)
For years CDISC data standards implementers have struggled to find good implementation examples and use cases beside...
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June 14, 2022
6 Key Trials for Understanding Adaptive Designs for Clinical Trials
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
Driving Global Data Collaboration for COVID-19
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
On Kappler's 'Graphical Comparison of Simon two-stage designs'
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
Continuous Monitoring for Blinded Sample Size Reestimation
In most instances of blinded sample size re-estimation, the timing of the interim analysis that determines whether the...
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June 6, 2022
The TOGETHER Trial Journey: Interview with Ofir Harari
The award-winning TOGETHER Trial was designed with the vision of ensuring that COVID-19 therapies are both effective...
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June 2, 2022
Digital Transformation for Clinical Trials
How can clinicians at the forefront of modern clinical trials and statisticians at the forefront of advanced...
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May 31, 2022
What it means to be a lead analyst on a Global COVID-19 Trial
The TOGETHER Trial for COVID-19 therapies, designed by clinical trial specialists at Cytel won the Society for Clinical...
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May 27, 2022
How to Use a Living HTA Approach to Demonstrate Value in Real-Time
When submitting systematic literature reviews to a Health Technology Assessment authority, high volumes of research...
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May 26, 2022
Method of Estimation with application to the COVID-19 Pandemic
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
Leveraging Advanced Statistical Software to Optimize Clinical Development
Traditionally, clinical trials are expensive, long in duration, and have low success rate. But with the advent of rich...
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May 17, 2022
Society of Clinical Trials names TOGETHER "Trial of the Year"
Early in the pandemic, it became clear that many of the COVID-19 therapies being tested in wealthier nations, were not...
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May 16, 2022
Cytel & ARCS Collaborate to Strengthen Early Phase Capabilities
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
Estimator Choice in Synthetic Control Arm Analyses
Synthetic control arm (SCA) methods are statistical methods that are seeing rapidly increasing use in comparative...
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May 5, 2022
Interview with Grammati Sarri on Moderating an Issue Panel 2022
While randomized control trials remain the industry gold-standard for regulatory and reimbursement submissions, there...
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May 4, 2022
Optimizing Human-Machine Partnership for Up-To-Date Evidence
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
Adaptive Designs for Early Phase Development: Are the questions right?
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
An Interview with Gabriel Tremblay on his Poster Contributions to ISPOR US 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
Reinventing Clinical Trial Design: Digital Development
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
Insights on the New ADaM guidelines and Europe Interchange 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
Cytel’s Single Arm Trials Panel Selected as a Part of ISPOR 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
Bayesian Statistics and Its Applications: New Webinar by Professor Yuan Ji
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
Join Cytel’s HEOR Consultants at ISPOR US 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
Career Perspectives: Interview with Charles Warne, Associate Director of Biostatistics
In this edition of the Career Perspectives series, I interview Charles Warne, Associate Director of Biostatistics at...
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April 8, 2022
Robust Trial Design Under Treatment and Enrollment Uncertainty
The planning and optimization of a clinical trial is beset by uncertainties: knowledge of treatment effects, the...
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April 7, 2022
Bridging the gap between oncology clinical trials and real-world data: evidence on replicability of efficacy results using German claims data
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
Time Check: Developing New Therapeutics
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
A Spotlight on Our Scientific Community
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
How to Use Historical Data to Mitigate Clinical Trial Risk
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
The Fundamentals of Real World Evidence in Oncology Drug Development
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
WINTER WEEKEND READ: Increased Adoption of Innovative Designs
Every year, sponsors hesitating to use a complex innovative clinical trial design routinely miss opportunities to...
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March 8, 2022
How to conduct better time-to-event analysis with delayed treatment effects
The issue of delayed treatment effects in immuno-oncology was demonstrated during a FDA-Industry sponsored workshop...
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February 22, 2022
How and Why to Implement Optimal Adaptive Promising Zone Designs
When determining the best possible statistical design for a particular trial, large pharmaceuticals and small biotechs...
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February 18, 2022
WINTER WEEKEND READ: Role of Data Strategy in Clinical Development Success
Data is the most crucial asset of any clinical trial and hence, sponsors cannot jeopardize collecting clean...
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February 17, 2022
A Data Manager’s Role in Supporting a Rare Disease Clinical Study
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
Measuring Estimates and Confidence Intervals in Adaptive settings?
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
WINTER WEEKEND READ: Tops Tips and Tricks from the Good Data Doctor
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
How can an optimized data strategy support your clinical program?
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
WINTER WEEKEND READ: Model-Based Enrollment Forecasting
The ability to conduct data-driven and quantitatively rigorous feasibility studies, is often key to successful trial...
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February 2, 2022
How to Overcome Common Challenges to Patient Recruitment Projections
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
Winners of The Promising Zone Quiz
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
Career Perspectives: Interview with Jessica Bhoyroo, Clinical Data Manager
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
Watch out, the FDA Rejection Criteria are Now in Place
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 21, 2022
How to Use and Interpret the Results of a Platform Trial
For our first Winter Weekend Read, Cytel presents How to Use and Interpret the Results of a Platform Trial, a JAMA...
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January 20, 2022
Is Borrowing Outcomes from US or China the Future for Rare Conditions?
Limited patient populations resulting in small study sample sizes is a difficulty associated with the development of...
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January 19, 2022
What’s Ahead for Clinical Trial Design?
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
Year-End Roundup: Your Favorite Blog Posts of 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
Approaches in Adaptive Group Sequential Clinical Trials
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
CDISC SDTM and ADaM: An Explosive 2021 Ending!
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
Is Promising Zone Design Optimal?
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
Conditional Powers Vs Bayesian Predictive Power for Adaptive Sample Size Reassessment
Despite the debate in the scientific community on adaptive sample size reassessment (SSR), noteworthy developments have...
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December 7, 2021
Anna Forsythe on Aligning Clinical Strategy with Regulatory and Market Objectives
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” Process
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
Dr. Julia Edwards Findings Promising Zone Designs
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
Using Single Arm Trials for HTA Submissions: Dr. Heeg and Maria Rizzo
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
Using Tech to align Regulatory and Market Access Evidence strategies
Traditionally, the teams responsible for clinical development and regulatory submissions do not consult the market...
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November 15, 2021
Optimal Promising Zone Designs: What Biotechs Need to Know
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
Championing RWE & HEOR at Virtual ISPOR Europe 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
Evolving the Study Design Process: An ACT Webcast by Dr. Yannis Jemiai
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
Keeping the Promise: Ten Year Anniversary of the Promising Zone Design
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
Join Cytel for HEOR Insights at ISPOR Europe 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
Empowering Trial Selection: An ACT Webcast by Dr. Yannis Jemiai
A good clinical study design performs well not only under the ideal target scenario. Statisticians should be able to...
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October 29, 2021
Designing Platform Trials
A platform trial, a type of Master Protocol, is an experimental infrastructure to evaluate multiple treatments and/or...
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October 27, 2021
Leveraging Staged Investment Strategy for Funding Novel Therapies
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
The Benefits of Using Basket Studies in Oncology
Currently, there are many treatment options for Cancer such as, Immunotherapy, Radiation Therapy, Chemotherapy etc. If...
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October 21, 2021
Measuring Non-Adherence and Non-Persistence
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
Strategic Clinical Trial Design Unlocks Innovative Opportunity
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 15, 2021
Applications of Master Protocols in a Global Health Context
Almost 3000 registered trials were performed in COVID-19 and a majority of them have been small and likely...
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October 14, 2021
Weighting and Prioritization for Trial Selection: New Webinar
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
Non-adherence and Non-persistence
‘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
The Rapidly Evolving Need for Master Protocols
Master Protocols are advanced and innovative clinical trial designs that can evaluate multiple therapies and disease...
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October 5, 2021
The Importance of Traceability
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
Dr. Kyle Wathen talks about the Need for Statistical Innovation
The COVID-19 pandemic elevated the challenge of designing and executing clinical trials within a substantially...
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September 30, 2021
Transportability Analysis - An interview with Miguel Hernán
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
How to leverage model-informed drug development for rare diseases
While there is a plethora of rare diseases, some 7000 diseases and counting, one needs to consider the statutory...
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