JSM 2005 Online Program

Abstract #304477

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:	222
Type:	Topic Contributed
Date/Time:	Tuesday, August 9, 2005 : 8:30 AM to 10:20 AM
Sponsor:	Biopharmaceutical Section
Abstract - #304477
Title:	Measuring Risk-benefit as Primary Endpoint To Assess Two Non-inferior Drugs in Cancer Patients
Author(s):	Sofia Paul*+
Companies:	Eli Lilly and Company
Address:	3590 Callowell Ct, Carmel, IN, 46032, United States
Keywords:	noninferiority ; historical data ; risk-benefit ; toxicity-free survival
Abstract:	In order to prove benefit from an experimental drug, either similar or superior efficacy or better safety compared to an existing drug has to be shown. Noninferiority of overall survival is used to establish similar efficacy as the active drug. Sufficient historical evidence is needed to obtain an adequate estimate of the active drug effect. In case of lack of historical data, it is difficult to interpret the results of the noninferiority results. A new risk-benefit measure is presented to compare the experimental and active control drugs. This is particularly important where there is a lack of historical data. Toxicity-free survival is the measure, which compares the survival distributions of the two arms without any occurrences of severe toxicity. This is defined as the time from randomization to the first date of any severe toxicity or death due to any cause. Toxicity-free survival is censored at the date of the last contact for patients who are still alive and who did not experience toxicity.

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