Abstract #300382

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JSM 2002 Abstract #300382
Activity Number: 237
Type: Invited
Date/Time: Tuesday, August 13, 2002 : 2:00 PM to 3:50 PM
Sponsor: WNAR
Abstract - #300382
Title: Combining Information From Clinical Trials and Observational Studies to Evaluate Safety
Author(s): Cindy Christiansen*+
Affiliation(s): Boston University
Address: 200 Springs Road (152), Building 70, Bedford, Massachusetts, 01730, USA
Keywords: randomized controlled trials ; vulnerable populations
Abstract:

Randomized Controlled Trials (RCTs) for drug efficacy and safety often exclude or under-represent potentially vulnerable patient populations, such as the elderly and those with comorbid conditions. After drug approval and marketing, identification of safety concerns in vulnerable populations emerges slowly because of difficulties making causal inference with observational or administrative data. In this talk, we describe methodology and applications for combining different types of research data to evaluate safety of drugs. Combining information to study health care safety of non-drug therapies where RCTs are uncommon also is discussed.

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Revised March 2002