An Approach to Design Adaptive Clinical Trials With Time-to-Event Outcomes Based on a General Bayesian Posterior Distribution.

ABSTRACT: Clinical trials are an integral component of medical research. Trials require careful design to, for example, maintain the safety of participants and to use resources efficiently. Adaptive clinical trials are often more efficient and ethical than standard or non-adaptive trials because they can require fewer participants, target more promising treatments, and stop early with sufficient evidence of effectiveness or harm. The design of adaptive trials is usually undertaken via simulation, which requires assumptions about the data-generating process to be specified a priori. Unfortunately, if such assumptions are misspecified, then the resulting trial design may not perform as expected, leading to, for example, reduced statistical power or an increased Type I error. Motivated by a clinical tr

SUBMITTER: McGree JM 

PROVIDER: S-EPMC12510400 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature