JSM 2004 - Toronto

Abstract #300959

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Activity Number: 182
Type: Topic Contributed
Date/Time: Tuesday, August 10, 2004 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #300959
Title: Survival Analysis in Medical Device Clinical Studies with Heterogeneous Samples
Author(s): Barbara Krasnicka*+ and Chang S. Lao
Companies: U.S. Food and Drug Administration and U.S. Food and Drug Administration
Address: 1350 Piccard Dr. HFZ-542, Rockville, MD, 20850,
Keywords: survival analysis ; heterogeneous samples
Abstract:

A number of methods of medical treatment effect evaluation, e.g., Kaplan-Meier product limit estimator, Cox proportional hazards regression model and the log rank test, have been well established in survival analysis. However, these methods have problems connected with the heterogeneity of individual patients in clinical studies, for instance, with misspecification of regression model, biases of treatment effect comparison, and loss of power. We intend to overview types of heterogeneity and to show how to handle such problems in practice. An additional difficult issue arises in survival analysis in the case of correlated data (e.g., multicenter studies, hip, dental, or ear devices). Some approaches, in particular frailty models, that help to overcome the correlated data problem will be discussed.

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Revised March 2004