When would a surrogate endpoint be used in a clinical trial?
A surrogate endpoint is a clinical trial endpoint used as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself, but rather is expected to predict that clinical benefit.
What is the difference between surrogate and clinical endpoints?
Unlike clinical endpoints, surrogate endpoints do not represent direct clinical benefit, but instead predict clinical benefit. For example, tumor shrinkage can be used as a surrogate endpoint for longer survival in clinical trials for drugs intended to treat some cancers.
What is a surrogate marker in research?
A surrogate end point, or marker, is a laboratory. measurement or physical sign that is used in therapeutic trials. as a substitute for a clinically meaningful end point that is a. direct measure of how a patient feels, functions, or survives. and that is expected to predict the effect of the therapy.
What is an example of a surrogate outcome?
An example is blood pressure reduction as a surrogate risk for stroke, for a well-studied class of antihypertensive agents. Level 3 is a nonvalidated surrogate outcome, yet one established to be reasonably likely to predict clinical benefit for a. specific disease setting and class of intervention.
Is a biomarker a surrogate endpoint?
A surrogate endpoint is a marker—such as a biomarker or other measure—that is expected to predict, but is not itself a measure of clinical benefit, and can thus be substituted for a clinical endpoint.
Is blood pressure a surrogate endpoint?
Background: Blood pressure is considered to be a leading example of a valid surrogate endpoint.
What does endpoint mean in clinical trial?
Listen to pronunciation. (END-poynt) In clinical trials, an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial.
What is a surrogate endpoint biomarker?
A surrogate endpoint has been defined as ‘a biomarker intended to substitute for a clinical endpoint’, the latter being ‘a characteristic or variable that reflects how a patient feels, functions, or survives'[4].
What is a surrogate endpoint Mcq?
A surrogate endpoint is “a laboratory measure or a physical sign that is intended to be used as a substitute for a clinically meaningful endpoint” [3].
What is the endpoint in clinical trials?
In clinical trials, an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial.
What is surrogate outcome measures?
A surrogate endpoint is a physical measurement of a specific outcome which is considered to be a valid predictor (or representative) of the real outcome or final result. In simple words, a surrogate endpoint is like a measurable indicator that can help us know what the real result is.
How do you validate a surrogate endpoint?
Validating a surrogate endpoint requires providing evidence based justifications, often from RCTs, that achievement effects from the surrogate endpoint reliably predicts achievement of clinically important effects on a clinically meaningful endpoint [1-6]. A good example is cholesterol.
What is a surrogate endpoint in cancer research?
A surrogate endpoint is usually proposed on the basis of a biologic rationale. In cancer studies with survival time as the primary endpoint, surrogate endpoints frequently employed are tumour response, time to progression, or time to reappearance of disease, since these events occur earlier and are unaffected by use of secondary therapies.
When can adaptive design be based on a surrogate endpoint?
FDA guidance states that where a potential surrogate endpoint exists that is correlated with the primary endpoint, and the primary endpoint itself is difficult or slow to ascertain, an adaptive design can be based on the potential surrogate endpoint.
Why adoptive trials for cancer patients?
For patients and advocates, adaptive trials and surrogate endpoints increase the likelihood that patients receive the most beneficial treatment for their cancer subtype at an earlier point in their disease.