Stratified randomization for platform trials with differing experimental arm eligibility.

ABSTRACT:

Background

Platform trials facilitate efficient use of resources by comparing multiple experimental agents to a common standard of care arm. They can accommodate a changing scientific paradigm within a single trial protocol by adding or dropping experimental arms-critical features for trials in rapidly developing disease areas such as COVID-19 or cancer therapeutics. However, in these trials, efficacy and safety issues may render certain participant subgroups ineligible to some experimental arms, and methods for stratified randomization do not readily apply to this setting.

Methods

We propose extensions for conventional methods of stratified randomization for platform trials whose experimental arms may differ in eligibility criteria. These methods balance on a prespecified s

SUBMITTER: Selukar S 

PROVIDER: S-EPMC8478711 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature