A “surrogate marker” can be defined as “ …
a laboratory measurement or physical sign that is used in therapeutic trials as a substitute for a clinically meaningful endpoint that is a direct measure of how a patient feels, functions, or survives and is expected to predict the effect of the therapy
.”
5
The primary …
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 drug?
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 an example of a surrogate outcome?
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 are the primary reasons for the use of surrogate endpoints in medical research?
Investigators use a surrogate endpoint
when the endpoint of interest is too difficult and/or expensive to measure routinely
and when they can define some other, more readily measurable, endpoint, that is sufficiently well correlated with the first to justify its use as a substitute.
Is death a surrogate outcome?
Surrogate markers are used
when the primary endpoint is undesired
(e.g., death), or when the number of events is very small, thus making it impractical to conduct a clinical trial to gather a statistically significant number of endpoints.
What is the role of surrogate mother?
A “surrogate mother” is
a woman who, for financial or other reasons, agrees to bear a child for another woman who is incapable to conceive herself
.
What is the difference between surrogate and clinical endpoints?
An endpoint is the primary outcome that is being measured by a clinical trial. … A surrogate endpoint is a
substitute
for a clinical endpoint used in trials where the use of a clinical endpoint might not be possible or practical (if, for example, a drug’s direct benefits would take many years to measure).
Is blood pressure a surrogate endpoint?
Background: Blood pressure is considered to be a leading example of
a valid surrogate endpoint
.
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.
What is a surrogate marker of disease?
A “surrogate marker” can be defined as “ …
a laboratory measurement or physical sign that is used in therapeutic trials as a substitute for a clinically meaningful endpoint that is a direct measure of how a patient feels, functions, or survives and is expected to predict the effect of the therapy
.”
5
The primary …
What are investigational medications?
An investigational drug can also be called
an experimental drug
and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials: If the drug is safe and effective. How the drug might be used in that disease.
What surrogate means?
It’s a woman who gets artificially inseminated with the father’s sperm. They then carry the baby and deliver it for you and your partner to raise. A traditional surrogate is
the baby’s biological mother
. That’s because it was their egg that was fertilized by the father’s sperm. Donor sperm can also be used.
Why are secondary endpoints studied?
Understanding Clinical Trials
Secondary endpoints answer
other relevant questions about the same study
; for example, whether there is also a reduction in disease measures other than death,
33
or outcomes rated by patients such as quality of life
34
.
What is a primary study endpoint?
Listen to pronunciation. (PRY-mayr-ee END-poynt)
The main result that is measured at the end of a study to see if a given treatment worked
(e.g., the number of deaths or the difference in survival between the treatment group and the control group).
What is a clinical endpoint study?
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
. The endpoints of a clinical trial are usually included in the study objectives.
