منابع مشابه
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...
متن کاملEvaluating candidate principal surrogate endpoints.
SUMMARY Frangakis and Rubin (2002, Biometrics 58, 21-29) proposed a new definition of a surrogate endpoint (a "principal" surrogate) based on causal effects. We introduce an estimand for evaluating a principal surrogate, the causal effect predictiveness (CEP) surface, which quantifies how well causal treatment effects on the biomarker predict causal treatment effects on the clinical endpoint. A...
متن کاملThe perils of surrogate endpoints.
Our goals in medicine are (i) to improve the quality of patients’ lives, (ii) help them to live longer, and (iii) to do so at a reasonable cost. These are our true endpoints: health status, survival, and cost. It is thus entirely consistent with this point of view that these are the fundamental concepts that can be united in a formal cost–utility analysis. These endpoints remain the best measur...
متن کاملStatistical 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...
متن کاملSurrogate endpoints and FDA's accelerated approval process.
There is interest in approaches allowing more rapid availability of new interventions, particularly for diseases providing risks of death or serious illness. The accelerated-approval regulatory process is intended to address this need by allowing marketing of interventions shown to have strong effects on measures of biological activity, if those measures are potential "surrogates" for true meas...
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ژورنال
عنوان ژورنال: British Journal of Cancer
سال: 1993
ISSN: 0007-0920,1532-1827
DOI: 10.1038/bjc.1993.369