6 Innovative Trial Design Videos

Posted by Cytel

Jan 26, 2018 9:03:00 AM

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The  Cytel YouTube Channel hosts a wealth of video presentations from Cytel experts as well as external industry and academic speakers about various aspects of clinical trial designs and their implementation.  In this blog, we've gathered 6 popular resources from the channel on topics from quantitative decision-making through to overcoming challenges in management of oncology trials. Read on to learn more and access the videos. 

Multi-Arm Multi-Stage (MAMS) module in East

With an increasing interest in platform designs and other innovative designs that involve multiple comparisons over multiple stages, the importance of Multi-Arm Multi-Stage ( MAMS) designs is rising. East's MAMS module facilitates the design, simulation and monitoring of such trials in a streamlined manner, using group sequential, p-value combination, and closed testing principle approaches to strongly control the type 1 error (false positive rate). In this abbreviated video, Cytel's Pantelis Vlachos and Cyrus Mehta walk through the capabilities. 

 

Challenges Faced by Statisticians and Data Managers in Oncology 

In this video our Tim Connolly describes some of the most pressing challenges faced by statisticians and data managers specifically working on oncology studies and presents strategies to overcome them.  He explores issues from the length of time to reach clinical endpoints and trial length variability, to capturing and analyzing data consistently using RECIST.  

AstraZeneca: Decision-Making in Early Clinical Development

Paul Frewer takes a deep dive into AstraZeneca's consistent approach to quantitative decision-making.  The method ensures that studies are designed from the outset with the decision in mind.  Importantly, once results are available they are interpreted against a pre-determined framework, allowing clear decisions to be made more quickly.

 

 

Promising Zone Design 'VALOR' Trial Described by the Sponsor

 In this popular video Dr  Adam Craig discusses the thinking behind the VALOR trial's sample size re-estimation strategy. The promising zone design implements an unblinded sample re-estimation after an interim look, but only if conditional power during the interim look falls within a designated promising zone.  Watch the video and learn how the approach helped to mitigate trial risks. 

 

 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 reasons, planning reasons, or business reasons. In this video Yannis Jemiai, Senior VP at Cytel looks at examples of where prediction goes off course, and how East's Predict module can help resolve these issues. 

 

Asking the Right Questions of Your Data: Experiences with Model-Informed Drug Development

Use of Model-Informed Drug Development techniques can help mitigate uncertainty by examining data from across clinical studies and allowing us to make more assumptions in a hypothesis generating fashion. In this 10 minute video, Cytel's Director of Quantitative Pharmacology and Pharmacometrics Cecilia Fosser introduces us to some of the techniques that can be applied. 

 

 

 

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Topics: East PREDICT, Cytel Videos, Adaptive Clinical Trials, Multi-Arm Studies, pharmacometrics, Multi-Arm Multi-Stage Studies, biostatistics, EAST 6.4, adaptive designs, model-informed-drug-development

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