Conducting RWE studies on treatments for chronic conditions: A conversation with Dr. Sebastian Schneeweiss

As the real-world evidence (RWE) field has evolved, so, too, has the amount of available knowledge regarding how to design and conduct RWE studies on the safety and effectiveness of medical interventions. Especially in chronic disease areas, RWE is an important tool to complement learnings from randomized controlled trials (RCTs) and to inform decision-making about how treatments perform in clinical practice. 

In a recent paper published in Endocrine Reviews, co-authors Sebastian Schneeweiss, M.D., Sc.D., and Elisabetta Patorno, M.D., Dr.P.H., summarize learnings on how to conduct RWE studies in diabetes and other chronic conditions. The comprehensive review paper explores the key considerations for researchers as they generate evidence to inform regulatory, payer, and health technology assessment decision-making, including the importance of transparency in studies, the use of fit-for-purpose data, and ways to avoid bias in study design.

We spoke with Dr. Schneeweiss, Professor of Medicine and Epidemiology at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, about the paper, and how it aims to increase researchers’ understanding of how to conduct decision-quality studies that reach causal conclusions about how patients are treated in the real world.