JSM Preliminary Online Program
This is the preliminary program for the 2009 Joint Statistical Meetings in Washington, DC.

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Activity Number: 342
Type: Invited
Date/Time: Tuesday, August 4, 2009 : 2:00 PM to 3:50 PM
Sponsor: Section on Bayesian Statistical Science
Abstract - #303120
Title: The Role of Meta-Analysis in Assessing Adverse Drug Effects
Author(s): Joel B. Greenhouse*+
Companies: Carnegie Mellon University
Address: Department of Statistics, Pittsburgh, PA, 15213,
Keywords: Meta-Analysis ; Sensitivity Analysis
Abstract:

Meta-analysis is an essential methodology for synthesizing evidence, particularly in the biomedical and social sciences. Quantitative research synthesis is frequently used to accumulate evidence about questions of interest; it can also be used to investigate the generalizability of research results, and to investigate alternative explanations for observed associations. In this talk, we discuss the role of meta-analysis in the assessment of drug safety considerations and consider the strengths and weaknesses of evidence generated from research synthesis. As a case study to help illustrate some of these issues, we consider the evidence from a meta-analysis of randomized controlled trials that the FDA used to inform their decision to issue a black box warning concerning the risk of suicidality in children who use antidepressants.


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