Real‐World Evidence for Assessing Pharmaceutical Treatments in the Context of COVID‐19

The emergence and global spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in an urgent need for evidence on medical interventions and outcomes of the resulting disease, coronavirus disease 2019 (COVID-19). Although many randomized controlled trials (RCTs) evaluating treatments and vaccines for COVID-19 are already in progress, the number of clinical questions of interest greatly outpaces the available resources to conduct RCTs. Therefore, there is growing interest in whether nonrandomized real-world evidence (RWE) can be used to supplement RCT evidence and aid in clinical decision making, but concerns about nonrandomized RWE have been highlighted by a proliferation of RWE studies on medications and COVID-19 outcomes with widely varying conclusions. The objective of this paper is to review some clinical questions of interest, potential data types, challenges, and merits of RWE in COVID-19, resulting in recommendations for nonrandomized RWE designs and analyses based on established RWE principles.