Abstract #302165

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JSM 2003 Abstract #302165
Activity Number: 452
Type: Contributed
Date/Time: Thursday, August 7, 2003 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #302165
Title: Extrapolating Clinical Trials Results Using an Observational Database
Author(s): Yun Li*+ and Kevin J. Anstrom
Companies: Duke Clinical Research Institute and Duke University
Address: 1227 Holly Hill Dr., Durham, NC, 27713-6058,
Keywords: survival analysis ; parametric models ; observational study
Abstract:

To determine the clinical and economic impact of a new therapy, it is often necessary to estimate the lifetime survival benefit relative to standard care. Typically, clinical trials are designed to test hypotheses related to short-term efficacy. In this paper, we present two methods for estimating lifetime survival using observational data from comparable patients with long-term follow-up. Our proposed methods are applied to published results from the MADIT-2 trial comparing Implantable Cardioverter Defibrillator (ICD) to conventional therapy. Maximum follow-up was four years for the trial and 14+ years for the observational database. In both approaches, we identified patients from the database that met the entrance criterion for MADIT-2 trial and were treated using conventional therapy. For method one, we modeled the cohort's survival using Kaplan-Meier estimates over the observed follow-up period, and the Weibull distribution beyond it. For method two, we assumed an age-based hazard function estimated using polynomial functions. The estimated life expectancy for the conventional therapy arm, which is the area under the survival curve, was virtually identical using either method.

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