Adaptive Design with Bayesian Informed Interim Decisions: Application To a Randomized Trial of Mechanical Circulatory Support.

ABSTRACT:

Background

Cardiovascular and oncology trials increasingly require large sample sizes and long follow-up periods. Several approaches have been developed to optimize sample size including sample size re-estimation based on the promising zone approach. With time-to-event endpoints, methods traditionally used to test for treatment effects are based on proportional hazards assumptions, which may not always hold. We propose an adaptive design wherein using interim data, Bayesian computation of Predictive Power (PP) guides the increase in sample size and/or the minimum follow-up duration.

Methods

PROTECT IV is designed to evaluate mechanical circulatory support device vs. standard of care during high-risk percutaneous coronary intervention with the initial enrolment of 1252 patien

SUBMITTER: Mukherjee R 

PROVIDER: S-EPMC12579667 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature