Prentice's approach and the meta-analytic paradigm: a reflection on the role of statistics in the evaluation of surrogate endpoints

Biometrics. 2004 Sep;60(3):724-8. doi: 10.1111/j.0006-341X.2004.00222.x.

Abstract

We put a perspective on the strengths and limitations of statistical methods for the evaluation of surrogate endpoints. Whereas using several trials overcomes some of the limitations of a single-trial framework (Prentice, 1989, Statistics in Medicine 8, 431-440), arguably the evaluation of surrogate endpoints can never be done using only statistical evidence but such evidence should be seen as but one component in a decision-making process that involves, among others, a number of clinical and biological considerations. We briefly present a hierarchical framework that incorporates ideas from Prentice's work and is uniformly applicable to different types of surrogate and true clinical outcomes.

Publication types

  • Comparative Study

MeSH terms

  • Biometry / methods*
  • Clinical Trials as Topic / statistics & numerical data*
  • Endpoint Determination / statistics & numerical data*
  • Humans
  • Interferon Type I / therapeutic use
  • Likelihood Functions
  • Macular Degeneration / drug therapy
  • Macular Degeneration / physiopathology
  • Meta-Analysis as Topic*
  • Models, Statistical
  • Recombinant Proteins
  • Visual Acuity / drug effects

Substances

  • Interferon Type I
  • Recombinant Proteins