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Validation of surrogate end points in multiple randomized clinical trials with failure time end points

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  • Tomasz Burzykowski
  • Geert Molenberghs
  • Marc Buyse
  • Helena Geys
  • Didier Renard

Abstract

Before a surrogate end point can replace a final (true) end point in the evaluation of an experimental treatment, it must be formally ‘validated’. The validation will typically require large numbers of observations. It is therefore useful to consider situations in which data are available from several randomized experiments. For two normally distributed end points Buyse and co‐workers suggested a new definition of validity in terms of the quality of both trial level and individual level associations between the surrogate and true end points. This paper extends this approach to the important case of two failure time end points, using bivariate survival modelling. The method is illustrated by using two actual sets of data from cancer clinical trials.

Suggested Citation

  • Tomasz Burzykowski & Geert Molenberghs & Marc Buyse & Helena Geys & Didier Renard, 2001. "Validation of surrogate end points in multiple randomized clinical trials with failure time end points," Journal of the Royal Statistical Society Series C, Royal Statistical Society, vol. 50(4), pages 405-422.
    • Handle: RePEc:bla:jorssc:v:50:y:2001:i:4:p:405-422
    DOI: 10.1111/1467-9876.00244
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