Abstract #300531

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JSM 2003 Abstract #300531
Activity Number: 118
Type: Topic Contributed
Date/Time: Monday, August 4, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #300531
Title: Statistical Methods to Analyze Matched-Pair Survival and Longitudinal Data in Medical Device Clinical Studies
Author(s): Chang S. Lao*+
Companies: Food and Drug Administration
Address: 15429 Narcissus Way, Rockville, MD, 20853-1747,
Keywords: matched-pair ; correlated survival ; frailty
Abstract:

The matched-pair design is frequently applied to medical device time-to-event survival studies. The experimental and control treatments are randomly assigned to different locations, or sites within the same patient, such as bilateral or multilateral skin graft, dental, ophthalmic, and knee and hip devices. Several statistical approaches are used to analyze such correlated matched-pair data, which include unstratified and stratified Cox proportional hazard regression, random-effect frailty, Gamma frailty, and other models. A real example of composite cultured skin graft for the treatment of autograft donor sites is analyzed to illustrate these approaches. Several patient covariates, such as treatment, total body surface-area burned, and others, are also explored.

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