New England Journal of Medicine
April 2, 2020 Vol. 382 No. 14
Creating a Framework for Conducting Randomized Clinical Trials during Disease Outbreaks
Natalie E. Dean, Ph.D., et al
Conducting trials of novel interventions during infectious disease emergencies, such as the ongoing Covid-19 pandemic, is increasingly recognized as important for determining the efficacy of potential vaccines and therapies. Clinical trials to evaluate investigational interventions are being implemented as part of the broader efforts to control the spread of an infectious disease and to improve patient outcomes. In such circumstances, however, it can be challenging to acquire the necessary evidence about the effects of the interventions to inform future patient care and public health planning, in part because of the unpredictable size, geographic location, and duration of outbreaks.