Seamless phase 2/3 design for trials with multiple co-primary endpoints using Bayesian predictive power.

ABSTRACT: Seamless phase 2/3 design has become increasingly popular in clinical trials with a single endpoint. Trials that define success based on the achievement of all co-primary endpoints (CPEs) encounter the challenge of inflated type 2 error rates, often leading to an overly large sample size. To tackle this challenge, we introduced a seamless phase 2/3 design strategy that employs Bayesian predictive power (BPP) for futility monitoring and sample size re-estimation at interim analysis. The correlations among multiple CPEs are incorporated using a Dirichlet-multinomial distribution. An alternative approach based on conditional power (CP) was also discussed for comparison. A seamless phase 2/3 vaccine trial employing four binary endpoints under the non-inferior hypothesis serves as an example. O

SUBMITTER: Yang J 

PROVIDER: S-EPMC10792895 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature