A generalized calibrated Bayesian hierarchical modeling approach to basket trials with multiple endpoints.

ABSTRACT: A basket trial simultaneously evaluates a treatment in multiple cancer subtypes, offering an effective way to accelerate drug development in multiple indications. Many basket trials are designed and monitored based on a single efficacy endpoint, primarily the tumor response. For molecular targeted or immunotherapy agents, however, a single efficacy endpoint cannot adequately characterize the treatment effect. It is increasingly important to use more complex endpoints to comprehensively assess the risk-benefit profile of such targeted therapies. We extend the calibrated Bayesian hierarchical modeling approach to monitor phase II basket trials with multiple endpoints. We propose two generalizations, one based on the latent variable approach and the other based on the multinomial-normal hiera

SUBMITTER: Chi X 

PROVIDER: S-EPMC11323483 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature