Statistical evaluation of surrogate endpoints: a systematic review

Statistical evaluation of surrogate endpoints: a systematic review

Results Prentice’s operational criteria, proportion of treatment effect explained and relative effect were the original techniques for evaluating surrogacy. These led to the development of several approaches for surrogate evaluation, namely; principal stratification, direct and indirect effects, meta-analytical (including the surrogate threshold effect) and information theory. Each methodologic...

Statistical Issues in Evaluation of Surrogate Endpoints

Among the most important issues in the design of a clinical trial is the selection of the primary endpoint. Fleming et al. (1998) provided two criteria to govern its selection: the endpoint should be (i) sensitive to treatment effects, and (ii) clinically relevant. Endpoints that directly reflect how a patient feels, functions, or survives have clear clinical relevance; we refer to these as tru...

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

Statistical validation of surrogate endpoints: is bone density a valid surrogate for fracture?

In the treatment of osteoporosis using anti-resorptive agents there has been increasing interest in quantifying the relationship between fracture endpoints and surrogates such as bone mineral density (BMD) or bone turnover markers. Statistical methodology constitutes a critical component of assessing surrogate validity. Depending on study designs, data resources, and statistical methods used fo...

Surrogate Endpoints in Medicine

A surrogate endpoint is defined as a biomarker intended to substitute for a clinical endpoint, such as an incidence, or mortality. The evidence supporting the linkage of a biomarker to accurately substitute for a clinical endpoint may be derived from epidemiologic studies, clinical trials, in vitro analysis, animal models, and simulated biologic systems. Analytical epidemiological studies of th...