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Validation of surrogate end points in multiple randomized clinical trials with failure time end points
Author(s) -
Burzykowski Tomasz,
Molenberghs Geert,
Buyse Marc,
Geys Helena,
Renard Didier
Publication year - 2001
Publication title -
journal of the royal statistical society: series c (applied statistics)
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.205
H-Index - 72
eISSN - 1467-9876
pISSN - 0035-9254
DOI - 10.1111/1467-9876.00244
Subject(s) - end point , bivariate analysis , computer science , surrogate endpoint , time point , statistics , randomized controlled trial , point (geometry) , data mining , reliability engineering , mathematics , medicine , engineering , surgery , pathology , real time computing , philosophy , geometry , aesthetics
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.