Routine Prospective Safety Surveillance for New Drugs, Vaccines, and Other Biologic Products

Project Title Routine Prospective Safety Surveillance for New Drugs, Vaccines, and Other Biologic Products
Date Posted
Sunday, April 24, 2016
Status
Complete
Deliverables
Description

The Mini-Sentinel pilot has developed the capacity to perform prospective routine observational active surveillance of newly approved medical products as experience with these products accumulates in near real time. These Prospective Routine Observational Monitoring Program Tools (PROMPT) will enable FDA to assess the occurrence of a fixed number of pre-specified health outcomes of interest that may occur in association with use of newly approved medical products. The program’s emphasis is on signaling of potential excess risks rather than formal assessment of causal relationships. As such, a small number of surveillance methods will be implemented through a library of programs that can be modified to accommodate specific agents, outcomes, populations, and time periods for evaluation. This approach requires that signals be carefully followed up to understand the explanation for the finding. The team has developed an overall users’ guide detailing the process for utilizing the current system, as well as a detailed technical users’ guides for its cohort matching surveillance method, self-controlled design method, and group sequential design methods. 

Workgroup Leader(s)

Richard Platt MD, MSc; Grace Lee MD, MPH; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA 

Workgroup Members

Patrick Archdeacon MD, MS; Janelle Charles PhD; David Graham MD, MPH; Mark Levenson PhD; Rita Ouellet-Hellstrom PhD, MPH; Simone Pinheiro ScD MSc; Marsha Reichman PhD; Azadeh Shoaibi MS, MHS; Robert Temple MD; Ram Tiwari PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Michael Nguyen MD; Antonio Paredes PhD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Mary Beth Ritchey PhD; Center for Devices and Radiological Health, FDA, Silver Spring, MD

Rongmei Zhang PhD; Division of Biometric VII, Office of Biostatistics, Office of Translation Sciences, FDA, Silver Springs, MD

Sean Hennessy PhD, PharmD; Charles Leonard PharmD, MSCE; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA

Jeffrey Brown PhD; Martin Kuldorff PhD; Darren Toh ScD; Katherine Yih PhD, MPH; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA

Ryan Carnahan PharmD, MS, BCPP; Elizabeth Chrischilles PhD, MS; Department of Epidemiology, University of Iowa College of Public Health, Iowa City, IA

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

Lesley Curtis PhD; Duke Clinical Research Institute and Duke University School of Medicine, Durham, NC

Denise Boudreau PhD, RPh; Andrea Cook PhD; Jennifer Nelson PhD; Robert Wellman MS; Onchee Yu MS; Biostatistics Unit, Group Health Research Institute, and University of Washington, Seattle, WA

James Floyd MD, MS; Susan R. Heckbert MD, PhD; University of Washington, Seattle, WA

Data Sources
Mini-Sentinel Distributed Database (MSDD)