The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials

Clinical trial endpoints must be carefully and intentionally selected so that the results of the trial can be used to inform policy- and decision-making. The relative importance of potential endpoints often depends on the stakeholder, with patients having different preferences to policymakers and regulators. The set up of clinical trials for COVID-19 was problematic, as endpoints that could be reasonably measured did not always match the efficacy endpoints usually required by guideline panels. Thus, different endpoints were used, which made the timely comparison and evaluation of interventions difficult. Here we discuss the evolution of the COVID-19 landscape and the effect this is having on the selection of consistent and measurable clinical trial endpoints. Using appropriate endpoints is crucial for researchers to offer the most reliable, valid, and interpretable results possible. Thorlund et al. discuss considerations when selecting appropriate endpoints for outpatient COVID-19 clinical trials. Improvements in patient outcomes during the COVID-19 pandemic have necessitated changes to the outcomes being assessed.

Automated summary

Clinical trial endpoints should be carefully selected to inform policy- and decision-making, considering the preferences of different stakeholders. The selection of endpoints for COVID-19 clinical trials has been problematic, as they did not always match the usual efficacy endpoints required by guideline panels. This has made it difficult to compare and evaluate interventions timely. Selecting appropriate endpoints is crucial for researchers to provide reliable, valid, and interpretable results.