JSM 2011 Online Program

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Abstract Details

Activity Number: 402
Type: Topic Contributed
Date/Time: Tuesday, August 2, 2011 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #302640
Title: Adaptive Clinical Trial Designs: Advantages Over 'Standard' Group Sequential Designs?
Author(s): Cyrus Mehta*+ and Scott Emerson*+ and Keaven Anderson*+ and Roger Lewis*+
Companies: Cytel Inc. and University of Washington and Merck & Co., Inc. and Harbor-UCLA Medical Center
Address: 675 Massachusetts Avenue, Cambridge, MA, 02139, , , , 351 N. Sumneytown Pike, North Wales, PA, 19454, , , ,
Keywords: Clinical trial ; Adaptive design ; Group sequential ; Operating characteristics
Abstract:

The focus of this panel session will be on issues in clinical trial design, specifically comparing the advantages and disadvantages of "the newer" adaptive clinical trial designs and "the more familiar" group sequential trial designs. Content will be based on a discussion and structured debate amongst the renown leading expert panelists on the ability of each type of trial design (adaptive design vs. 'standard' group sequential design) to adequately address the scientific and statistical issues of randomized clinical trials. Case studies will be used to illustrate issues involved including aspects of sample size modification and population enrichment, two aspects for which adaptive designs are often suggested.


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