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Abstract Details

Activity Number: 513
Type: Contributed
Date/Time: Wednesday, August 1, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305878
Title: Data Monitoring in Clinical Trials Using Innovative and Practical Bayesian Tool
Author(s): Soumi Lahiri*+
Companies: GlaxoSmithKline
Address: 1250 South Collegeville Road, Collegeville, PA, 19426, United States
Keywords: Interim analysis ; Bayesian ; Predictive probability

Interim analyses are often planned in large clinical trials to rule out futility of an ineffective drug or to stop the trial due to dramatic benefit. Several methods have been developed to assess efficacy and safety of the study drug during interim. A Bayesian prediction, based on simulation, is proposed as a useful and practical tool for quantitative monitoring of clinical trials. Monitoring tools are discussed for binary, continuous and time-to-event endpoints. Numerical examples are used to illustrate the methodology further.

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