Adaptive Population Enrichment in a Phase III Oncology Trial Webinar

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Pantelis Vlachos, Cytel statistician and adaptive trial expert, shares his deep knowledge of population enrichment, the theory, and thoughts on applying adaptive rules to achieve more flexible design scenarios.

 

With rising costs of clinical trials and a decline in the discovery of blockbuster drugs, the pharmaceutical industry is gradually moving away from the “one size fits-all” idea. Pantelis presents a way to achieve this as well as the software for it. Population enrichment, the prospective use of any patient characteristic to obtain a study population in which detection is more likely that it would be in an unselected population, is explored. Through a case study in angiosarcoma (AS) we present a practical design that ultimately leads to greater power, shorter duration and smaller sample size.

 

The benefits include:

• Seamless phase 2/3 with Phase 2 objective to select the right patient population and Phase 3 to confirm the effect in the selected population
• Allows adaptation in sample size and patient population
• Mitigate the risk of uncertainty around treatment effect and patient population
• Precision medicine to target the right treatment for the right patient population

 

What you will learn

• How to design an adaptive enrichment trial in East
• How to deal with the special challenges of Event-driven trials when considering an adaptive enrichment design

 

Your Presenter

Pantelis Vlachos, Senior Director, Cytel Strategic Consulting


Before joining Cytel, Pantelis Vlachos was a Principal Biostatistician for Merck Serono in Geneva and taught statistics at Carnegie Mellon University for 12 years. His research focus is adaptive designs, but mainly from a Bayesian perspective.

Pantelis is a key contributor to the continuing development and training in the use of the East software package. Pantelis also has served on editorial boards of several scientific journals and online archives, including Managing Editor of “Bayesian Analysis” journal.