Sensitivity of Safety Analyses to Minor Changes in Specifications Applied to Test Case

Project Title Sensitivity of Safety Analyses to Minor Changes in Specifications Applied to Test Case
Date Posted
Friday, September 15, 2017
Status
In progress
Description

Design and analysis in a safety investigation of medical products in the Sentinel System often require tailored specifications to the products and outcomes of interest. The goal of this project is to uncover differences in specifications which may be thought of as minor but may greatly impact medical products’ safety analyses. This project has two main phases. The first phase compares the statistical code and specifications for two sets of analyses run in the Sentinel System. These analyses were of special interest because they were thought to have similar design and analysis elements (or specifications) to each other but led to larger-than-expected differences in results on a particular outcome. The second phase of this project runs a multifactorial experiment on a test case. This experiment slightly co-varies multiple specifications at a time and measures their impact on a few safety outcomes. The findings from this project will inform choices and standardization of certain specifications in future drug safety investigations. This will help minimize potential bias and facilitate replication of study findings or design of sensitivity analyses.

Workgroup Leader(s)

Rima Izem PhD; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

Judy Maro PhD, MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Workgroup Members

Michael Nguyen MD; Mark Levenson PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Ting-Ying Huang PhD; Laura Shockro BA; Laura Hou MPH, MS; April Duddy MS; Andrew Petrone MPH; Ella Pestine MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Health Outcome
acute myocardial infarction (AMI)
gastrointestinal hemorrhage
intracranial hemorrhage
Population / Cohort
All individuals
Time Period
November 1, 2010 – September 30, 2015
Data Sources
Truven Health MarketScan® Research Databases
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