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Cancer Control Research

1R13DK077555-01
Allison, David B.
DESIGN, ANALYSIS, & INTERPRETATION OF RCTS IN OBESITY

Abstract

DESCRIPTION (provided by applicant): Obesity is a serious condition that is associated with and believed to cause much morbidity, reduced quality of life, and decreased longevity. The most recent figures from the Centers for Disease Control indicate that obesity continues to increase in prevalence in the overall US population. Currently available treatments are only modestly efficacious and rigorously evaluating new (and in some cases existing) treatments for obesity is clearly in order. Conducting such evaluations to the highest standards and so that they are maximally informative requires an understanding of best methods for the conduct of randomized clinical trials in general and how they can be tailored to the specific needs of obesity research in particular. In response to recent Medicare calls for increased evaluation of obesity treatments, a FDA meeting on open questions in the conduct of obesity treatment trials, and high profile editorials in general medical journals questioning the way we design, execute, analyze, and interpret randomized clinical trials in obesity research, we propose a two-day meeting in which leading obesity researchers and methodologists convene to discuss best practices for randomized clinical trials in obesity. The meeting will take place in December of 2006 and be attended by scientists from academia, government, and industry.

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