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

Franklin, Jessica M.; Lin, Kueiyu Joshua; Gatto, Nicolle M.; Rassen, Jeremy A.; Glynn, Robert J.; Schneeweiss, Sebastian

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.