JSM 2005 Online Program

Abstract #304014

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	315
Type:	Topic Contributed
Date/Time:	Tuesday, August 9, 2005 : 2:00 PM to 3:50 PM
Sponsor:	Biopharmaceutical Section
Abstract - #304014
Title:	INB and WTP in the Benefit-risk Analysis of RCTs
Author(s):	Andrew Willan*+
Companies:	Research Institute, Sick Kids
Address:	555 University Avenue, Toronto, ON, M5G 1E2, Canada
Keywords:	Benefit-risk analysis ; Randomize clinical trials ; Incremental net benefit ; Willingness-to-pay
Abstract:	There is growing interest in (and an FDA mandate for) presenting the analysis of randomized clinical trials (RCTs) in a benefit-risk format. The objective of such an analysis is to incorporate all outcomes of interest, including the health benefits and the risks of side-effects, into one analysis. The challenge is to establish a means of trading-off between the various benefits and risks to provide a single overall measure with which to compare treatment arms. In an attempt to do this, we develop a model by borrowing the concepts of incremental net benefit (INB) and the willingness-to-pay (WTP) from the field of Health Economics. The proposed model also can take into account between-treatment differences in costs and patient acceptance. A brief review of the literature concerning multiple outcomes in RCTs will be given, followed by illustrative examples.

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