Mitigating Study Power Loss Caused by Clinical Trial Disruptions Due to the COVID-19 Pandemic: Leveraging External Data via Propensity Score-Integrated Approaches

Abstract

The spread of COVID-19 has created tremendous challenges to ongoing clinical studies essential to finding effective treatments and cures for a myriad of diseases, with some studies having suspended enrollment altogether. This perspective article focuses on the loss of power in clinical studies disrupted by the pandemic. It introduces an innovative use of the recently developed propensity score-integrated approaches: salvaging those stopped studies for which restarting enrollment is not feasible, by integrating external patients with data already collected to recover the loss of study power due to the premature stopping. A hypothetical example is provided to illustrate how to implement these methods while preserving study integrity.