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 ?
In this study, we are evaluating "Total Lymphocyte Count, Haemoglobin level, Body Mass Index and serum Albumin as low cost surrogate markers for disease progression in HIV/AIDS.
03 Contract Award Notice - Successful Supplier(s): Replicate methods adopted for biomarker identification in a previous project titled SUrrogate markers for Micro- and Macro-vascular hard endpoints for Innovative diabetes Tools.
3) In this study we showed an improvement in different surrogate markers of CD risk, such as TGs, TCh, LDL, TCh/HDL ratio, confirming data previously published (4) and the long-term efficacy of this strategy.
Patients with cancer are evaluated through different oncology laboratory markers, aiming at translation to clinical findings, to evaluate progression of disease as well as translating to overall survival, as surrogate markers.
Alternatively, antibiotic exposures might just be surrogate markers for an infectious trigger that is actually associated with IBD.
In addition, associated changes in surrogate markers of immunologic protection are observed.
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.
Surrogate markers are biomarkers that can be used as substitutes for clinically meaningful disease endpoints.
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.
Surrogate markers like response under therapy (complete remission, partial remission) or time to progression and laboratory parameters turn out to be invalid therapy aims.