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Abstract Details

Activity Number: 555
Type: Topic Contributed
Date/Time: Wednesday, August 1, 2012 : 2:00 PM to 3:50 PM
Sponsor: Section on Bayesian Statistical Science
Abstract - #306368
Title: Bayesian Approach in Phase III Outcome Prediction Aiming Early Phases Decisionmaking
Author(s): Yuanjun Shi and Bronwyn Loong and Huyuan Yang*+
Companies: Millennium Pharmaceuticals, Inc. and Harvard University and Millennium Pharmaceuticals, Inc.
Address: 35 landsdowne st, cambridge, MA, , use
Keywords: Phase I/II ; Bayesian imputation

The failure rate and cost in clinical development in oncology drugs are very high, this is mainly caused by predictions based on small sample size and noncomparative phase I/II trials are not reliable to support decision making and design of phase III clinical trials. Modeling clinical trials in a Bayesian framework enhances both statistical and medical effectiveness in clinical trial operations and decision making, by drawing information from the collection of prior studies. Phase III data will be imputed based on Phase I/II data towards clinical response predictions. The proposed modeling can access more information from Phase I/II studies and improve the efficiency in decision making

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