The COVID-19 Natural History Master Protocol effort involves the development of a protocol designed to identify multiple COVID-19 cohorts to support a variety of on-demand queries and subsequent inferential studies. The protocol will be adaptable to various data sources with clinically rich data and will include specific populations of interest, such as the pediatric population, pregnant women, and other vulnerable populations identified by FDA. The implementation of the Natural History protocol will prioritize data source capabilities, such as: a) the capacity to form stable population-based cohorts that can be refreshed quickly and reliably over time, b) deep on-site pharmacoepidemiology experience with a research record of both descriptive and inferential studies, and c) demonstrated analytic capability to support rapid on-demand queries which support identification of the natural history of COVID-19. Expert infectious disease specialists and pharmacoepidemiologists will lead development of this protocol and its implementation in various data sources in the Sentinel network.
Wei Hua, MD, PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Katherine Yih, PhD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Vincent Lo Re, MD, MSCE; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania
Michael Nguyen, MD; Robert Ball, MD, MPH, ScM; Brian Kit, MD, MPH; Sarah Dutcher, PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Darren Toh, ScD; Meighan Rogers Driscoll, MPH; Candace Fuller, PhD, MPH; Maria Kempner, MPH; Christine Draper; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA