Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database

Project Title Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database
Date Posted
Tuesday, October 13, 2015
Status
Complete
Deliverables
Description

This report presents different postmarket surveillance methods applicable to the distributed data setting with rare outcomes. The workgroup 1) reviewed the statistical and epidemiology literature on methods for survival outcomes that incorporate adjustment for confounders using a causal inference approach; 2) assessed the methods’ applicability to Mini-Sentinel and made recommendations on which strategies were best suited for use within this setting, where rare events, a distributed data environment, and sequential testing introduce new complications; and 3) evaluated, via simulation, the most promising existing approaches and new approaches tailored to the Mini-Sentinel setting.

Workgroup Leader(s)

Andrea J. Cook PhD; Biostatistics Unit, Group Health Research Institute, Seattle, WA and Department of Biostatistics, University of Washington, Seattle, WA

Workgroup Members

Azadeh Shoaibi PhD, MHS; Ram C. Tiwari PhD; Rima Izem PhD; Rongmei Zhang PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Susan R. Heckbert MD, PhD; Department of Epidemiology, University of Washington, Seattle, WA

Lingling Li PhD; Department of Population Medicine, Harvard Pilgrim Health Care Center and Harvard Medical School, Boston, MA

Robert D. Wellman MS; Biostatistics Unit, Group Health Research Institute, Seattle, WA

Jennifer C Nelson, PhD, Biostatistics Unit, Group Health Research Institute and Department of Biostatistics, University of Washington, Seattle, WA

Data Sources
Mini-Sentinel Distributed Database (MSDD)
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