TL32: Futility Analyses
*Anthony James Rodgers, Merck & Co, Inc.
Futility analyses are becoming more commonly used in clinical trials. There are statistical issues that arise from the use of futility analyses that warrant a collaborative discussion between the FDA and Industry. Some, but not all, of these issues include the following: type I error adjustment, power (particularly in terms of pediatric studies), use of Bayesian predictive probability and conditional power.
Questions for discussion: 1.) Why adjust the type I error at all since there is no scientific basis for adjusting for type I error inflation in the context of binding futility analyses? 2.) In the context of pediatric studies where there is often limited power but are conducted as part of a pediatric written request is the utility of futility analyses viewed differently from a regulatory standpoint? 3.) What are the benefits/risks of different strategies for optimally conducting futility analyses (e.g., Bayesian approaches, timing, etc.)?
April 30 - May 22, 2013
Invited Abstract Submission Open
June 4, 2013
Online Registration Opens
August 9 - August 23, 2013
Invited Abstract Editing
August 23, 2013
Short Course materials due from Instructors
August 26, 2013
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC