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

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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June 9, 2021
Selecting a Clinical Trial Design: How Broadly Should You Explore?
When selecting clinical trial designs, how many design options should a sponsor explore? Would a sponsor feel more...
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June 2, 2021
A Data-Infused Approach to De-Risking Clinical Trials
For many decades the Pareto Frontier has been employed by actors in the private sector to evaluate and understand the...
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December 21, 2020
Year-End Roundup: Your Favorite Blog Posts of 2020
2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog...
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December 15, 2020
Satisficing, Optimizing and Globally Optimizing Trial Designs
When designing clinical trials, biostatisticians and clinical development teams are often faced with a conundrum. Given...
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December 9, 2020
7 Key Features of Strategic Clinical Trial Design
As a part of Cytel’s Advanced Design Framework, a new Framework for the statistical design of clinical trials, Cytel...
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December 3, 2020
New Whitepaper: Reimagining Clinical-Trials
Increasing Clinical Development Productivity Using Statistics and Cloud-Computing The need for Re-imagining Clinical...
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November 18, 2020
We can design over 100,000 clinical trials in less than an hour
The current state of the clinical trials industry faces a challenge that was only hypothetical three or four years ago....
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November 11, 2020
Interview with Yannis Jemiai: Advanced Design Framework
The widespread use of cloud-computing has altered the clinical trial design process. Whereas three or four years ago,...
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November 10, 2020
Key Design Considerations for Platform Trials
Platform trials are a new type of clinical trials where multiple interventions can be evaluated simultaneously against...
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November 4, 2020
Cytel Introduces Advanced Design Framework: Part 3 - Communication Techniques to Ensure Alignment on Data-Driven Clinical Trial Designs
Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought leaders that draws on...
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October 29, 2020
Advanced Design Framework: Part 2 - A Quantitative Evaluation Approach
Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought leaders that draws on...
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October 21, 2020
Advanced Design Framework: Part 1 - Exploration of Design Space
Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought-leaders after a decade...
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October 15, 2020
An Advanced Design Framework for Clinical Development in the Era of Cloud-Computing
For over a decade, advanced trial design techniques have promised efficient trials with accelerated timelines,...
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October 9, 2020
Cyrus Mehta on Increasing the Power of Platform Trials
Even before the era of COVID-19, significant attention was channeled to the overwhelming potential of adaptive MAMS...
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October 1, 2020
Improve Trial Design with Sequential Design and Sample Size
Methods involving Group Sequential Designs are one of the earliest deviations from a traditional two-arm clinical trial...
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September 28, 2020
Advantages of platform designs for investigating COVID-19 therapies
Cytel has recently designed and implemented the TOGETHER Trials, funded by the Bill & Melinda Gates Foundation to...
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September 21, 2020
Novel Adaptive Platform Trial for COVID-19 Therapies
Cytel has designed and implemented a novel adaptive platform trial for early stage COVID-19. The severity of the...
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July 27, 2020
Introduction to Population Enrichment by Dr. Thomas Burnett
Cytel is conducting a webinar series on complex innovative trial designs. Dr. Thomas Burnett, Senior Research Associate...
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June 11, 2020
Adaptive Bayesian Methods: The Secret Weapon in COVID-19 Vaccine Development
A recent Cytel panel led by Vice President of Strategic Consulting Natalia Muhlemann evaluated the role that Bayesian...
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June 10, 2020
Group Sequential Designs and Sample Size Re-estimation
Cytel is conducting a webinar series that introduces biostatisticians to some of the more commonly used complex...
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May 27, 2020
Group Sequential Designs and Sample Size Re-estimation
In this blog, we speak with Christopher Jennison, Professor of Statistics at the University of Bath, UK. Professor...
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May 7, 2020
COVID-19: Trials, Designs and Tools for Promising Results - A Virtual Panel Discussion
An extraordinary amount of global research is underway as the COVID-19 pandemic continues to evolve and spread...
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January 30, 2020
Designing Event-based Studies: Interview with Pantelis Vlachos
The Cytel Trial Design Innovations (CTDI) Webinar Series recently hosted a webinar on designing event-based studies....
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January 22, 2020
What could you accomplish with a fresh approach to your clinical data strategy?
In the quest for clinical success, we all strive for evidence packages of the highest quality. If the clinical data is...
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January 16, 2020
Adaptive Population Enrichment in a Phase III Oncology Trial
January’s Cytel Trial Design Innovations (CTDI) Webinar Series will feature Biostatistician and pioneering Bayesian...
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January 8, 2020
How to optimize your data strategy to drive success in clinical development
In clinical development, data is the vital ‘foundation’ that supports your programs. To successfully bring a promising...
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December 18, 2019
Year-End Roundup: Your Favorite Blog Posts of 2019
With only two weeks left for this fabulous year to end, we would like to thank all our blog subscribers and new readers...
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August 23, 2019
Advancing Medicines Development with External Controls
In place of collecting data from patients recruited for a trial who have been assigned to the control or...
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August 14, 2019
Keeping Clinical Trials on Track: A Statistician's Perspective
This article was originally published as part of a series by pharmaphorum in association with Cytel and is reproduced...
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July 22, 2019
Adaptive Design and Health Economic Analysis: Interview with Laura Flight
Health economics and adaptive design methods share common ground in that they both aim to support more efficient and...
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June 14, 2019
Flipping the paradigm-how should biotechs harness adaptive trials?
This article was originally published as part of a series by pharmaphorum in association with Cytel and is reproduced...
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February 8, 2019
Publication Reveals New Promise for Promising Zone Designs
A 2018 publication in the Biometrical Journal by Cytel’s Cyrus Mehta, Lingyun Liu and Sam Hsiao, ‘Optimal Promising...
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November 5, 2018
New publication addresses critical issues in ultra-orphan indications
Cytel biostatisticians Cyrus Mehta and Lingyun Liu, together with Charles Theuer, CEO of TRACON Pharmaceuticals have...
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September 7, 2018
Opportunities of FDA’s Innovative Trial Design Pilot Meeting Program
On August 29th 2018, the FDA announced (1) that it would be establishing a Complex Innovative Trial Design (CID) Pilot...
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March 16, 2018
Career Perspectives: Interview with Benjamin Esterni, Principal Biostatistician
At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking...
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February 27, 2018
Congrats to Lipopharma and CLINGLIO Consortium on Recent Grant Award
We extend our congratulations to Lipopharma and the CLINGLIO project consortium on their recent 6,15M€ grant award by...
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February 15, 2018
A Gatekeeping Procedure to Test a Group Sequential Design
A recent publication in Biometrics ‘A Gatekeeping Procedure to Test a Primary and a Secondary Endpoint in a Group...
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March 2, 2017
Case Study: Bayesian Decision-Making in a Phase 3 Oncology Design
We continue our case study series with this example of a Phase 3 design that uses Bayesian decision making combined...
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February 9, 2017
Inside an Oncology Statistician's Toolkit
In this blog, Adam Hamm, PhD, Director Biostatistics at Cytel shares some of the most important knowledge he uses in...
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January 30, 2017
Accelerating development with combined SAD/MAD approach
Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies. They...
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January 23, 2017
How to get the regulatory green light for your adaptive design?
As a group, Cytel had over 40 successful regulatory interactions last year, many of which supported approvals for...
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January 16, 2017
Adaptive Design Approaches from Cardiovascular Clinical Trialists Forum
The Global Cardiovascular Clinical Trialists Forum is a key event bringing together leading experts from across the...
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December 15, 2016
Adaptive Design CONSORT Extension Project: The Inside Scoop
In April, we interviewed NIHR research fellow Munya Dimairo about the paper, ‘Adaptive designs undertaken in clinical...
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December 2, 2016
Innovative Phase 3 Adaptive Enrichment Design in Oncology
At a recent Pfizer/ Cytel seminar on rare disease and oncology development, Cytel’s Lingyun Liu presented innovative...
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November 21, 2016
Infographic: 10 steps to consider before choosing an adaptive design
While adaptive designs can deliver significant benefits to clinical development- including ethical benefits for...
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November 9, 2016
New East Insights Video:Creating an SSR Design
Adaptive sample size re-estimation designs are an important part of the statistician's toolkit. In this first in a...
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November 1, 2016
Pharmacometrics tools of the trade: 4 factors to consider
Unlike statistics which has been around in some form for hundreds of years, pharmacometrics is, by comparison, a...
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October 7, 2016
Adaptive Designs: A Data Management Perspective
Adaptive designs have the potential to accelerate clinical development, and improve the probability of trial success....
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October 5, 2016
Challenges in Neuroscience Clinical Trials
While some progress has been made in terms of scientific development in Neuroscience and Neuropsychiatry indications,...
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September 29, 2016
Case studies:Learning from less-well understood adaptive designs
A paper "Best practices case studies for 'less well-understood' Adaptive designs", has been published by the DIA...
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September 9, 2016
Case Study:Seamless Phase 2/3 Design in Rare Disease
Challenge: Our client, an emerging biotechnology company, was preparing for the next stage of development for their...
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September 7, 2016
Overcoming challenges of 'Less Well Understood' Adaptive Designs
In the 2010 draft FDA ‘Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics', the agency...
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August 31, 2016
An Introduction to BLRM
Traditional rule-based approaches to dose escalation such as 3+3 are widely used in early clinical development. They...
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August 26, 2016
Sample Size Re-Estimation in Bioequivalence Trials with Small Samples
At the recent JSM in Chicago, Cytel’s Sam Hsaio and Lingyun Liu alongside Genentech's Romeo Maciuca, presented a...
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August 23, 2016
How does the T-Statistic stack up for finding MTD?
At the recent JSM meeting in Chicago, Cytel's Jim Bolognese presented the results of work he has conducted evaluating...
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August 17, 2016
Adaptive Designs: In Conversation with the NEJM
Following the recent publication of their review article Adaptive Designs for Clinical Trials in the New England...
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August 9, 2016
Operational and regulatory considerations in a promising zone trial
At the recent JSM Meeting, Cytel’s Yannis Jemiai presented the case study of the VALOR trial which used a promising...
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June 16, 2016
Determining the future course of your trial
Predicting the course of a clinical trial is something which people will always want to do-whether for statistical...
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May 31, 2016
EAST 6.4 Release: Interview with Yannis Jemiai
Last week, we were delighted to announce the release of East 6.4 bringing further cutting –edge approaches to the East...
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April 28, 2016
Adaptive Designs in Practice
Adaptive Designs in Practice: Interview with NIHR Research Fellow Munya Dimairo NIHR and University of Sheffield...
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