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Activity Number: 115 - Novel Statistical Methods for Emerging Problems in Modern Clinical Trials and Drug Development
Type: Topic Contributed
Date/Time: Monday, July 29, 2019 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #302905 Presentation
Title: Optimal Selection Procedures and Adaptive Designs for Seamless Phase 2/3 Clinical Trials
Author(s): Vladimir Dragalin*
Companies: Janssen R&D
Keywords: adaptive design; seamless Phase 2/3 trial; optimal selection rule; family-wise error rate; probability of correct selection; multiple treatments

Seamless Phase 2/3 clinical trials can accelerate drug development by evaluating multiple treatments in the first part of the trial and selecting one treatment for the second part for establishing its superiority in comparison with a control. Most of the research in this area has been focused on the control of the family wise type I error rate which is the probability of recommending at least one ineffective treatment at the end of the trial. Although, many selection rules have been considered, little research is devoted to the optimality of such selection procedures. We consider the probability of correct selection as a metric for evaluating and comparing different selection procedures and propose an optimality criterion based on average total number of subjects required to achieve the pre-specified probability of correct selection.

Authors who are presenting talks have a * after their name.

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