Meta-Analytic Approach to the Validation of Surrogate Endpoints: The Past Decade

• Activity Number: 113
• Type: Topic Contributed
• Date/Time: Monday, August 2, 2010 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Tomasz Burzykowski*+
• Companies: Hasselt University
• Keywords: surrogate endpoint ; validation ; meta-analytic approach

Abstract

Following the proposal of Daniels and Hughes (1997), Buyse et al. (2000) formalized and developed a framework for the validation of surrogate endpoints by using data from multiple clinical trials. The framework has been termed the meta-analytic approach to the validation of surrogate endpoints. In the past decade, the approach has become a focus of an intensive research. As a result, many methods have been developed. Moreover, a better understanding of the advantages and limitations of the approach has been acquired. In this paper, an attempt to summarize the benefits and issues will be undertaken, together with a description of the most recent solutions proposed to tackle some of the problems.