Statistical evaluation of surrogate endpoints: a systematic review

The Biomarker-Surrogacy Evaluation Schema: a review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints.

There are clear advantages to using biomarkers and surrogate endpoints, but concerns about clinical and statistical validity and systematic methods to evaluate these aspects hinder their efficient application. Section 2 is a systematic, historical review of the biomarker-surrogate endpoint literature with special reference to the nomenclature, the systems of classification and statistical metho...

Validation of Surrogate Endpoints in Advanced Solid Tumours: Systematic Review of Statistical Methods, Results, and Implications for Policy-makers

A unified framework for the evaluation of surrogate endpoints in mental-health clinical trials.

For a number of reasons, surrogate endpoints are considered instead of the so-called true endpoint in clinical studies, especially when such endpoints can be measured earlier, and/or with less burden for patient and experimenter. Surrogate endpoints may occur more frequently than their standard counterparts. For these reasons, it is not surprising that the use of surrogate endpoints in clinical...

Flexible surrogate marker evaluation from several randomized clinical trials with continuous endpoints, using R and SAS

The evaluation of surrogate endpoints is thought to be first studied by Prentice (1989), who presented a definition of a surrogate as well as a set of criteria. Freedman et al (2001) supplemented these criteria with the so-called proportion explained after notifying some drawbacks in Prentice’s approach. Buyse et al (2000) framed the evaluation exercise within a meta-analytic setting, thereby o...

Hard, harder, hardest: principal stratification, statistical identifiability, and the inherent difficulty of finding surrogate endpoints

In many areas of clinical investigation there is great interest in identifying and validating surrogate endpoints, biomarkers that can be measured a relatively short time after a treatment has been administered and that can reliably predict the effect of treatment on the clinical outcome of interest. However, despite dramatic advances in the ability to measure biomarkers, the recent history of ...