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

Abstract Details

Activity Number: 469
Type: Contributed
Date/Time: Wednesday, August 4, 2010 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #308051
Title: Assessing Treatment Effect in Clinical Trials with Dichotomous Endpoints
Author(s): Gang Jia*+
Companies: Merck & Co., Inc.
Address: 1517 Wynnemoor Way, Fort Washington, PA, 19034,
Keywords: Study design ; sample size ; dichotomous endpoints ; odds ratio ; relative risk ; treatmenr effect
Abstract:

Consider designing a two-arm parallel clinical trial in which the primary endpoint is a dichotomous variable. Results of a pilot study with the same dichotomous endpoint are available. In order to quantify the observed treatment effect, relative risk (RR) and odds ratio (OR) are two widely used measures. Their advantages and disadvantages have been discussed in literatures. However, the discussions have been focused on providing the measure with appropriate interpretation for medical community and patients. Here we'll look at the issue from study design perspective. Implications of using different treatment effect measures on sample size calculation will be examined, and an approach of choosing the "best" treatment effect measure will be proposed. The method will be evaluated under different assumptions on treatment effect.


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