Transparent reporting of adaptive clinical trials using concurrently randomised cohorts

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.

Citation:
Marschner IC, Jones M, Totterdell JA, …… Snelling TL, Tong SYC, …… Bowen A, Davis J, et al. Transparent reporting of adaptive clinical trials using concurrently randomised cohorts. BMJ Medicine; 2023;2(1).

Keywords:
Clinical trial; research design; statistics

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.