What is an example of a surrogate endpoint?

What is an example of a surrogate endpoint?

In simple words, a surrogate endpoint is like a measurable indicator that can help us know what the real result is. One example of this is cholesterol levels and the risk of having a heart attack. Generally, a high level of cholesterol in the bloodstream indicates a greater risk of having a heart attack.

What is surrogate endpoints of a study?

Listen to pronunciation. (SER-uh-gut END-poynt) In clinical trials, an indicator or sign used in place of another to tell if a treatment works. Surrogate endpoints include a shrinking tumor or lower biomarker levels.

What is FDA endpoint?

A clinical trial’s “endpoints” are measurements of what happens to people in the trial. When a trial is intended to evaluate the efficacy and safety of a new medical product or a new use of an approved product, its endpoints usually measure benefit.

Why would a surrogate endpoint be useful 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 outcome and endpoint?

The term outcome usually refers to the measured variable (eg, peak volume of oxygen or PROMIS Fatigue score), whereas an endpoint refers to the analyzed parameter (eg, change from baseline at 6 weeks in mean PROMIS Fatigue score).

Is a stroke a surrogate endpoint?

For example, surrogate endpoints are used when the clinical outcomes, like strokes, might take a very long time to study, or in cases where the clinical benefit of improving the surrogate endpoint, such as controlling blood pressure, is well understood.

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 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].

How are surrogate endpoints validated?

Candidate surrogate endpoints are still under evaluation for their ability to predict clinical benefit, while validated surrogate endpoints are supported by a clear mechanistic rationale and clinical data providing strong evidence that an effect on the surrogate endpoint predicts a specific clinical benefit.

What is meant by endpoint 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.

Which biomarker is considered as surrogate end points?

Blood pressure as an example of a biomarker that functions as a surrogate. AAPS J. 2006; 8: E146–E52. 8.

Is A1c a surrogate endpoint?

Hemoglobin A1c (HbA1c) reduction is a validated surrogate endpoint for reduction of microvascular complications associated with diabetes mellitus and has been used as the basis for approval of drugs intended to treat diabetes mellitus.

What is a validated endpoint?

A validated surrogate endpoint is one in which the treatment effect on the surrogate corresponds to the effect on the intended clinical outcome and hierarchies of validity are described in the literature [7,8]. For example, blood pressure has been shown to predict mortality from cardiovascular disease.

What is a surrogate measure?

What is the difference between an outcome and an endpoint?

What is an endpoint in NPI?

Endpoint Information: Endpoint is where the service can be accessed by a client application. Endpoint Type: Direct Address. SOAP URL.

What are examples of endpoints?

An endpoint is any device that is physically an end point on a network. Laptops, desktops, mobile phones, tablets, servers, and virtual environments can all be considered endpoints. When one considers a traditional home antivirus, the desktop, laptop, or smartphone that antivirus is installed on is the endpoint.