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