Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances

Abstract

Randomized trials are an essential tool to inform health care, policy, and regulatory decisions concerning the effects of medical interventions. Forethought and diligence in trial design, statistical approaches, implementation, and analysis are necessary to minimize trial modifications after participant enrollment, which can introduce methodological, ethical, feasibility, and analytical challenges. Amendments to trial procedures are common, and circumstances such as new safety or efficacy information, regulatory requirements, or changes in the standard of care can make those changes unavoidable.¹ Modifications can also introduce biases, raising doubts about the validity of the conclusion of a clinical trial.^2,3