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Activity Number: 494
Type: Topic Contributed
Date/Time: Thursday, August 10, 2006 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #306909
Title: General Statistical Issues and Applications for Survival Analysis in Medical Device Clinical Studies
Author(s): Chang S. Lao*+
Companies: U.S. Food and Drug Administration
Address: 1350 Piccard Drive, CDHR, Rockville, MD, 20850,
Keywords: censoring ; sample size ; prediction
Abstract:

Survival analysis is used frequently to analyze data from medical device clinical trials, radiation research, or post-approval studies, particularly for long-term follow-up implant studies, such as orthopedic (hip and knee implants), plastic surgery (breast implants), or cardiovascular (pacing lead and cardiovascular stents) devices. Practical applications, rather than theoretical approaches, are discussed in this paper. We discuss sample-size selections based on censoring mechanisms, examples of correlated survival in medical device trials, recurrent events of same or different types, random-effects frailty models, identification of prognostic covariates by Cox proportional hazard regression model, and prediction of future survival with validation based on parametric distributions (Weibull or Gompertz) using actual radiation research data from long-term beagle dog studies.

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