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Recently, the strategy for dose optimization in oncology has shifted toconduct Phase 2 randomized controlled trials with multiple doses. Optimalbiologic dose selection from Phase 1 trial data to determine candidate dosesfor Phase 2 trials has been gaining attention. This study proposes a noveladaptive cohort size determination method for optimal biologic dose-finding toaccelerate trials. The cohort size expansion is determined adaptively dependingon the toxicity and efficacy data of the ongoing trial. In a simulation, theproposed method shortened the trial duration and maintained accuracy. The trialduration was reduced by an average of approximately 20% compared with thenon-adaptive cohort size determination design. The cohort size expansion isdemonstrated using a simple example.

Adaptive Cohort Size Determination Method for Bayesian Optimal Interval Phase I/II Design to Shorten Clinical Trial Duration