Skip to main content

Mini-Sentinel: Sequential Testing Methods

Basic Details
Date Posted
Status
Complete
Description

Methods project to develop and evaluate a method to incorporate regression adjustment to control for confounding in a group sequential design framework, including a simulation study comparing the new approach to existing approaches.

Deliverable(s) (1)
Mini-Sentinel_Methods_Sequential-Testing-Report
Related Links
Related Link(s)
http://faculty.washington.edu/acook/software.html
Statistical Approaches to Group Sequential Monitoring of Postmarket safety Surveillance Data: Current State of the Art for use in the Mini-Sentinel Pilot
Workgroup Leader(s)

Andrea J. Cook, PhD; Biostatistics Unit, Group Health Research Institute, Seattle WA

Workgroup Member(s)

Ram C. Tiwari, PhD; Office of Biostatistics, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

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

Susan R. Heckbert, MD, PhD; Departments of Epidemiology and Pharmacy, University of Washington, Seattle, WA and Group Health Research Institute, Seattle, WA

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

Patrick J. Heagerty, PhD; Department of Biostatistics, University of Washington, Seattle, WA

Tracey L. Marsh, MS; Group Health Research Institute, Seattle, WA

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