Sequential Surveillance for Drug Safety in a Regulatory Environment

Project Title Sequential Surveillance for Drug Safety in a Regulatory Environment
Date Posted
Monday, March 5, 2018
Status
Complete
Description

Sequential surveillance for drug safety using electronic health data extends the concepts developed for sequential monitoring in randomized clinical trials and in post-licensure vaccine safety studies. Additional challenges in the postmarketing safety monitoring of drugs that can influence patterns of use and affect the composition of study populations include changing indications over time, time-varying exposures of long duration, the presence of a large number of potential confounding factors, and off-label use. The goal of this paper is to help those with an interest in regulatory science to develop and refine recommendations regarding which types of questions are most suitable for sequential surveillance and under what circumstances sequential surveillance will fit into the regulatory environment.

Workgroup Leader(s)

David Martin MD, MPH; Center for Drug Evaluation and Research, Office of the Center Director, FDA, Silver Spring, MD

Workgroup Members

Joshua J. Gagne PharmD, ScD; Sebastian Schneeweiss MD, ScD; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

Susan Gruber PhD, MPH, MS; Rima Izem PhD; Office of Biostatistics, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Jennifer Nelson PhD; Group Health Research Institute and University of Washington, Seattle, WA

Michael Nguyen MD; Rita P. Ouellet-Hellstrom PhD, MPH; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Darren Toh ScD, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Alexander M. Walker MD, PhD; WHISCON, Newton, MA

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