surrogate end point

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).
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Instituted in 1992, the accelerated approval program was designed to approve drugs to treat serious conditions on the basis of a surrogate end point.
In order to use a biomarker as a surrogate end point in a regulatory submission, researchers must evaluate the method for sensitivity, specificity, reproducibility, interobserver reliability, variability and bias (REF6).
CD4 cell count as a surrogate end point in HIV clinical trial, a meta analysis of studies of the AIDS clinical trials group.
Atherosclerotic changes can be measured by carotid intima-media thickness by B-mode ultrasound is surrogate end point in cardiovascular outcomes in clinical trials.
Yet, they write, "no systematic assessment of PFS as a surrogate end point in NSCLC has been reported to date" (Soria 2010).
But early endoscopic findings suggest that the added aspirin helps promote the appearance of new squamous epithelial islands in areas previously showing Barrett metaplasia, a promising surrogate end point, according to Dr.
The primary surrogate end point for response was RITS at surgery.
As the early data are validated by additional clinical trials, CTCs may become a surrogate end point for disease status, as opposed to waiting many months or years for end points such as disease progression and survival data.
These approvals can be based on a surrogate end point that is considered "reasonably likely" to predict clinical benefit, or on an effect on a clinical end point "other than survival or irreversible morbidity.
A validated surrogate end point is a laboratory measurement, or "biomarker," that, through a clinical trial of a pharmacologic agent, has been shown to predict a change in clinical outcome.
Midodrine received accelerated approval as ProAmatine in 1996 based on the surrogate end point of increase in 1-minute standing systolic blood pressure.
However, before any type of biomarker is used as a surrogate end point in the drug development process, it must be validated to ensure the confidence of regulatory bodies.