2017 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop

September 25–27, 2017 

Enjoy the slidesets from Cytel contributions at the ASA Biopharmaceutical Section Regulatory Industry Statistics Workshop

September 26, 2017

Yannis Jemiai
Cytel

Sample Size Re-Estimation: Controlling the Type-1 Error

 

Yannis Jemiai addresses uncertainty in trial design assumptions. He then analyzes one of the most popular adaptations, especially when using a promising zone approach.  
 

September 26, 2017

Jim Bolognese
Sam Hsiao
Cytel

Bayesian Study Design to Leverage Informative Prior Information

 

Screen Shot 2017-09-28 at 10.08.43 AMJim Bolognese and Sam Hsiao used two case studies to examine how to leverage informative prior information in study design.
 

September 26, 2017

Cyrus Mehta
Sam Hsiao
Lingyun Liu
Cytel

Efficiency Promising of Zone Designs

 
 With promising zone designs, efficiency is in the eye of the beholder.  Depending on the type of SSR rule adopted, an adaptive design may suffer a small power loss at the design stage.  But if the interim results are promising, then this will be more than compensated for at the interim monitoring stage.
 

September 26, 2017

Caroline Morgan
Cytel

PS4b Parallel Session

Caroline Morgan led discussion and shared DIA, FDA, and EMA perspectives on the uptake and application of adaptive designs across the industry.