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Activity Number: 189 - SBSS Student Paper Competition I
Type: Topic Contributed
Date/Time: Monday, August 8, 2022 : 2:00 PM to 3:50 PM
Sponsor: Section on Bayesian Statistical Science
Abstract #322196
Title: An Alternative Metric for Evaluating the Potential Patient Benefit of Response-Adaptive Randomization Procedures
Author(s): Jennifer Lauren Proper* and Thomas Murray
Companies: University of Minnesota Twin Cities and University of Minnesota
Keywords: Bayesian adaptive design; Binary outcomes; Decision theory; Group sequential; Phase II

When planning a group sequential clinical trial with a binary primary outcome that has severe implications for quality of, investigators may strive to find the design that maximizes in-trial patient benefit. In such cases, Bayesian response-adaptive randomization (BRAR) is often considered because it can alter the allocation ratio throughout the trial in favor of the treatment that is currently performing better. Although previous studies have recommended using fixed randomization over BRAR based on patient benefit metrics calculated from the realized trial sample size, these previous comparisons have been limited by failures to hold type I and II error rates constant across designs or consider the impacts on all individuals directly affected by the design choice. In this paper, we propose a metric for comparing designs with the same type I and II error rates that reflects expected outcomes among individuals who would participate in the trial if enrollment is open when they become eligible. We demonstrate that various implementations of group sequential BRAR offer modest improvements with respect to the proposed metric relative to conventional group sequential monitoring alone.

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

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