surrogate end point

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surrogate end point

A parameter or analyte measured to detect a pathologic condition when a more specific test either does not exist, is impractical or is not cost-effective. Cholesterol levels are “classic” surrogate markers of efficacy that are used in trials of statins which, by lowering serum cholesterol levels, are assumed to also reduce morbidity and mortality of cardiovascular disease (but which is not always the case).
References in periodicals archive ?
Support public health efforts to identify likely HAIs through electronic surveillance surrogate markers, such as the MedMined NIM (nosocomial infection marker) and improve tracking of antibiotic use
In addition, associated changes in surrogate markers of immunologic protection are observed.
Clinical studies will be complemented by comprehensive laboratory analyses to assess the strength and quality of vaccine-induced T cell responses using state-of-art assays, which will facilitate the discovery of surrogate markers of protective immunity.
Enrofloxacin administered to African penguins at 15 mg/kg PO q24h, whether in fish or pilled, is expected to achieve the surrogate markers of efficacy for bacteria with a minimum inhibitory concentration of 0.
Large clinical efficacy studies are extremely expensive and should not be initiated without insight to biological effect and the potential to measure biological effect via biomarkers, or surrogate markers relevant to the hypothesis.
Hernan, of the Harvard School of Public Health, Boston, and colleagues note that the introduction of combined therapy in 1996 has greatly improved surrogate markers such as CD4 cell count and HIV RNA levels among patients in the developed world.
1,2] The clinical development of superior treatment options and/or second-line therapies has been partly hampered by the lack of validated surrogate markers of treatment benefit.
The most important clinical objective is to prevent fractures, not to produce changes in surrogate markers like bone mineral density or biochemical markers of bone turnover, he emphasized.
We believe these microRNAs may potentially provide the basis for a broad range of Cepheid proprietary markers for Cancer-specific markers, Infection-specific markers, Inflammation-specific markers, and surrogate markers of complex regulatory mechanisms," said Cepheid CEO John Bishop.
I think when you're comparing two drugs that work by the same mechanism of action, it's reasonable to compare them using surrogate markers of efficacy.
Evidence for the "fitness" effect comes from the temporal association between loss of resistance phenotype and the steepest changes in surrogate markers.
In this paper I explore three issues: a) whether such surrogate markers are, in fact, more sensitive than gravimetric analysis of the uterus, b) whether they are needed to predict the estrogenicity of chemicals, and c) whether they are reliable and suitable for general adoption.