DIA 48th Annual Meeting
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FDA Draft Guidance on Multiple Endpoints in Clinical Trials
Track : Track 15: Statistical Science and Quantitative Thinking
Program Code: 234
Date: Tuesday, June 26, 2012
Time: 10:00 AM to 11:30 AM  EST
 Bruce Binkowitz, Merck Research Laboratories, United States
Kathleen Fritsch, FDA, United States
 Robert Temple, FDA, United States
 Frank Bretz, Novartis Pharma AG, Switzerland
Clinical trials evaluate effects of one or more treatments typically on multiple primary and secondary endpoints. This raises multiplicity issues if there are alternative paths in the trial for winning for treatment effects. In addition, clinical trials frequently evaluate treatment effects on subpopulations, perform interim analyses and use adaptive designs which add yet another dimension of multiplicity. All these increase the risk of making false conclusions about the treatment effects, if not handled properly. FDA, upon recognizing the importance of multiplicity, has recently developed draft guidance on this topic. This session will address issues of multiple comparison and the new draft guidance.

Learning Objectives:
Identify key issues, from a regulatory perspective, surrounding testing of multiple endpoints
Describe the key points of the draft FDA guidance
Discuss the topic of multiplicity in clinical trials.