Biochemical Markers as Surrogate Endpoints of Joint Disease
نویسندگان
چکیده
منابع مشابه
Biomarkers and Surrogate Endpoints in Drug Development: A European Regulatory View.
Purpose To give a European regulatory overview of the requirements on and the use of biomarkers or surrogate endpoints in the development of drugs for ocular disease. Methods Definitions, methods to validate new markers, and circumstances where surrogate endpoints can be appropriate are summarized. Results The key endpoints that have been used in registration studies so far are based on vis...
متن کاملComparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study
BACKGROUND The U.S. Food and Drug Administration (FDA) often approves new drugs based on trials that use surrogate markers for endpoints, which involve certain trade-offs and may risk making erroneous inferences about the medical product's actual clinical effect. This study aims to compare the treatment effects among pivotal trials supporting FDA approval of novel therapeutics based on surrogat...
متن کاملAbstracts of the NIH-FDA Conference “Biomarkers and Surrogate Endpoints: Advancing Clinical Research and Applications”
s of the NIH-FDA Conference “Biomarkers and Surrogate Endpoints: Advancing Clinical Research and Applications” Abstracts of the NIH-FDA Conference 188s of the NIH-FDA Conference 188
متن کاملSurrogate 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 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 کامل