How to use frailtypack for validating failure-time surrogate endpoints using individual patient data from meta-analyses of randomized controlled trials.

ABSTRACT:

Background and objective

The use of valid surrogate endpoints can accelerate the development of phase III trials. Numerous validation methods have been proposed with the most popular used in a context of meta-analyses, based on a two-step analysis strategy. For two failure time endpoints, two association measures are usually considered, Kendall's τ at individual level and adjusted R2 ([Formula: see text]) at trial level. However, [Formula: see text] is not always available mainly due to model estimation constraints. More recently, we proposed a one-step validation method based on a joint frailty model, with the aim of reducing estimation issues and estimation bias on the surrogacy evaluation criteria. The model was quite robust with satisfactory results obtained in simulation studi

SUBMITTER: Sofeu CL 

PROVIDER: S-EPMC6986733 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature