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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Establishment of a surrogate end point would bring new therapies to patients sooner, preventing death and encouraging the development of new targeted therapies
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).
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's 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.
While not endorsing HBV DNA as a reliable surrogate end point for long-term clinical outcomes, the panel did conclude that elevated HBV DNA is the "most important predictor" of cirrhosis or hepatocellular carcinoma in patients with chronic HBV infection.
IRESSA is approved in the United States under accelerated approval by the FDA (sub-part H) that enabled the drug to be approved on the basis of adequate and well-controlled clinical trials establishing that the drug product had an effect on a surrogate end point likely to predict clinical benefit in a serious or life threatening illness for which there is an unmet medical need.