Decentralized Clinical Trials: Best Practices In Moving Toward A Patient-Centric Research Model

By Lindsay McNair, MD, MPH, MSB

Several decades ago, almost all clinical trials for new medications were conducted within the relatively small community of academic medical centers. Gradually, this practice began to shift, with community hospitals, free-standing research sites, and physicians in private practice becoming involved as research sites. Still, the model of clinical trials remained based at medical institutions. In the last few years, and in conjunction with the increase in patient involvement in the design and conduct of research programs, there has been a notable increase in the idea of “virtual” or “decentralized” clinical trials.

While this term can be used in different ways, decentralized clinical trials are fundamentally a movement of clinical studies away from medical institutions. In this model, clinical studies are focused on bringing the clinical study directly to the participant and allowing data collection to be completed in a participant’s home or local community. This paper examines the nature of decentralized clinical trials, potential benefits and risks of this new paradigm, and best practices for maintaining regulatory and Institutional Review Board (IRB) compliance.