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Activity Number: 568 - Simulation Report for Designing Adaptive Clinical Trials: Current Practices and Recommendations to Industry
Type: Topic Contributed
Date/Time: Wednesday, August 2, 2017 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #323308 View Presentation
Title: Simulation Considerations for Multistage Adaptive Designs and Designs with Sample Size Re-Estimation: Type 1 Error Control and Beyond
Author(s): Greg Cicconetti* and Sergei Leonov and Yili L Pritchett and Michael Smith and Alan Hartford
Companies: Abbvie and ICON Clinical Research and MedImmune and Astellas and AbbVie
Keywords: simulation ; adaptive design
Abstract:

Multi-stage adaptive designs offer the flexibility to make prospectively defined changes to aspects of trial conduct. However, if we decide to entertain notions of introducing such changes it behooves us to understand well the repercussions. At an interim analysis a trial designer might envisage one or more opportunities to drop arms, change randomization scheme, increase sample size, etc. When one or more of these adaptive components are being considered, natural questions arise: Does the proposed adaptation maintain trial integrity vis-à-vis control of type I error? How often and when do we expect a particular adaptation to be implemented? If a sample size re-estimation option is considered, we would like to characterize the distribution of the final sample size. When we cannot appeal to analytically derived solutions, simulation provides a means to answer these questions and gain insight into how the considered adaptions play out under controlled circumstances where the simulator controls the data generation. We will discuss aspects of planning and summarizing findings in the context of simulation reporting.


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

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