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FDA Draft Guidance on Multiple Endpoints in Clinical Trials
Tuesday, June 26, 2012
10:00 AM to 11:30 AM
Bruce Binkowitz is a Senior Director in the Late Development Statistics Group for Merck and Co., Inc. He is the Biostatistical leader for all products in the Cardiovascular/Atherosclerosis franchise, and co-chair of the DIA Annual Meeting Statistics Track.
Kathleen Fritsch, FDA, United States
Dr. Temple is Deputy Center Director for Clinical Science of FDA’s Center for Drug Evaluation and Research and is Acting Director of the Office of Drug Evaluation I, which is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products.
Joined Novartis in 2004, currently Global Head of the Statistical Methodology group. Areas of expertise include dose-finding, multiple comparisons and adaptive designs. Adjunct Professor at Hannover Medical School (since 2007) and at Shanghai University of Finance and Economics (since 2010).
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 FDA, upon recognizing the importance of multiplicity, has recently developed draft guidance on this topic. This session will address issues of multiple comparison and the new draft guidance.
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.
Audio Synchronized to PowerPoint