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Project TitleStatistical Methods for Estimating Causal Risk Differences (PRISM)
Date Posted 3-08-2012
Project StatusComplete
Description Project to develop a new method for the distributed data setting to control for multiple confounders in the concurrent control design with a single time exposure, e.g., vaccine, assessing elevated rates of rare acute outcomes when the quantity of interest is a risk difference. The method proposed is applicable to both a single-time analysis and a group sequential analysis design.
Workgroup Leader(s)Andrea J. Cook, PhD, Biostatistics Unit, Group Health Research Institute and Department of Biostatistics, University of Washington, Seattle, WA
Workgroup MembersRobert D. Wellman, MS, Biostatistics Unit, Group Health Research Institute, Seattle, WA; Tracey L. Marsh, MS, Department of Biostatistics, University of Washington and Group Health Research Institute, Seattle, WA; Ram C. Tiwari, PhD, Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD; Michael D. Nguyen, MD, Estelle Russek-Cohen, PhD, and Zhen Jiang, PhD, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD; Jennifer C. Nelson, PhD, Biostatistics Unit, Group Health Research Institute and Department of Biostatistics, University of Washington, Seattle, WA
Data Sources 
Deliverables Mini-Sentinel (PRISM) Statistical Methods for Estimating Causal Risk Differences.pdf
Related Links examplecode.R.txt
gendata.R.txt
IPWseqmethods.R.txt
KeywordsMini-Sentinel, PRISM, statistical methods, estimation, causal risk differences, distributed data, postmarket safety surveillance, Cook, Wellman, Marsh, Tiwari, Nguyen, Russek-Cohen, Jiang, Nelson

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