This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 256
Type: Contributed
Date/Time: Monday, August 2, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307972
Title: Definition of a Responder in Clinical Trials for Alcohol Dependence
Author(s): Yun-Fei Chen*+ and Xiwen Ma
Companies: Eli Lilly and Company and University of Wisconsin-Madison
Address: 7438 Royal Oakland Dr., Indianapolis, IN, 46236,
Keywords: Responder Analysis ; Quantile Regression ; Alcohol Dependence ; COMBINE

Alcohol Dependence, is one of the leading causes of disability and mortality worldwide. Treatment for alcohol dependence varies for each individual and the investigation of the efficacy of pharmacotherapy is not always traightforward. While trial is conducted, the definition of a responder is not under consensus in the field. Current recommendation in allowing grace period to calcuate the percentage of patients without heavy drinking for the rest of the trial does not take into account of baseline difference. We propose an innovative framework of responder analysis using the change from baseline relationship of the primary end point and one major health outcome measure with quantile regression from COMBINE data. We provide not only a meaningful definition to a responder,but also the quantile regression approach could be generalized for the statistical analysis in the field.

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