Transparent reporting of adaptive clinical trials using concurrently randomised cohorts.

ABSTRACT: Adaptive clinical trials have designs that evolve over time because of changes to treatments or changes to the chance that participants will receive these treatments. These changes might introduce confounding that biases crude comparisons of the treatment arms and makes the results from standard reporting methods difficult to interpret for adaptive trials. To deal with this shortcoming, a reporting framework for adaptive trials was developed based on concurrently randomised cohort reporting. A concurrently randomised cohort is a subgroup of participants who all had the same treatments available and the same chance of receiving these treatments. The reporting of pre-randomisation characteristics and post-randomisation outcomes for each concurrently randomised cohort in the study is recommen

SUBMITTER: Marschner IC 

PROVIDER: S-EPMC10510920 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature