Improving Precision and Power in Randomized Trials for COVID-19 Treatments Using Covariate Adjustment, for Binary, Ordinal, and Time-to-Event Outcomes.

ABSTRACT: Time is of the essence in evaluating potential drugs and biologics for the treatment and prevention of COVID-19. There are currently over 400 clinical trials (phase 2 and 3) of treatments for COVID-19 registered on clinicaltrials.gov. Covariate adjustment is a statistical analysis method with potential to improve precision and reduce the required sample size for a substantial number of these trials. Though covariate adjustment is recommended by the U.S. Food and Drug Administration and the European Medicines Agency, it is underutilized, especially for the types of outcomes (binary, ordinal and time-to-event) that are common in COVID-19 trials. To demonstrate the potential value added by covariate adjustment in this context, we simulated two-arm, randomized trials comparing a hypothetical C

SUBMITTER: Benkeser D 

PROVIDER: S-EPMC7302221 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature