MASSACHUSETTS INSTITUTE OF TECHNOLOGY
OPERATIONS RESEARCH CENTER
FALL 2004 SEMINAR SERIES

DATE

Thursday, September 23, 2004

LOCATION: Room E40-298           TIME: 4:15pm

Reception immediately following in the
Philip M. Morse Reading Room, E40-106

SPEAKER

William DuMouchel
Vice-President, Research
Lincoln Technologies, Inc.

TITLE

Empirical Bayes Methods for Postmarketing Surveillance of Adverse Drug Reactions

ABSTRACT

     Because of practical limits in characterizing the safety profiles of therapeutic products prior to marketing, manufacturers and regulatory agencies perform post-marketing surveillance based on the collection of adverse drug reaction (ADR) reports ("pharmacovigilance"). The resulting databases, while rich in real-world information, are notoriously difficult to analyze using traditional techniques. Each report may involve multiple medicines, symptoms, and demographic factors, and there is no easily linked information on drug exposure in the reporting population. Data mining techniques, such as association finding, are being used to screen for previously unknown ADRs. This presentation will discuss attacks on two problems encountered during application of empirical Bayes methods to such data:

1) Interpreting polypharmacy effects due to frequent co-occurrence of multiple drugs in the same report, and

2) Coping with the very fine-grained adverse event coding system, called MedDRA Preferred Terms (PT), by clustering PTs that have similar ADR profiles across several thousand drugs