On model-based time trend adjustments in platform trials with non-concurrent controls.

ABSTRACT:

Background

Platform trials can evaluate the efficacy of several experimental treatments compared to a control. The number of experimental treatments is not fixed, as arms may be added or removed as the trial progresses. Platform trials are more efficient than independent parallel group trials because of using shared control groups. However, for a treatment entering the trial at a later time point, the control group is divided into concurrent controls, consisting of patients randomised to control when that treatment arm is in the platform, and non-concurrent controls, patients randomised before. Using non-concurrent controls in addition to concurrent controls can improve the trial's efficiency by increasing power and reducing the required sample size, but can introduce bias due to t

SUBMITTER: Bofill Roig M 

PROVIDER: S-EPMC9380382 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature