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 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 the difference between surrogate and clinical endpoints?
Unlike clinical endpoints, surrogate endpoints do not represent direct clinical benefit, but
insteadpredict 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 mean?
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 …
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.
When is a surrogate endpoint used?
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 endpoint?
An endpoint is
a remote computing device that communicates back and forth with a network to which it is connected
. Examples of endpoints include: Desktops. Laptops. Smartphones.
Is overall survival a surrogate endpoint?
Background. Progression-free survival (
PFS
) is a surrogate endpoint widely used for overall survival (OS) in oncology. Validation of PFS as a surrogate must be done for each indication and each intervention.
What is an exploratory endpoint?
Exploratory. Exploratory endpoints may include
clinically important events that are expected to occur too infrequently to show a treatment effect
or endpoints that for other reasons are thought to be less likely to show an effect but are included to explore new hypotheses.
What is a composite endpoint?
Composite endpoints in clinical trials are
composed of primary endpoints that contain two or more distinct component endpoints
. The purported benefits include increased statistical efficiency, decrease in sample-size requirements, shorter trial duration, and decreased cost.
What is a composite outcome?
Composite outcomes, in
which multiple end points are combined
, are frequently used as primary outcome measures in randomized trials and are often associated with increased statistical efficiency. However, such measures may prove challenging for the interpretation of results.
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 primary study endpoint?
(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 are primary and secondary endpoints in clinical trials?
The primary endpoint of a
clinical trial is the endpoint for which the trial is powered
. Secondary endpoints are additional endpoints, preferably also pre-specified, for which the trial may not be powered.
What’s a surrogate family?
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.
What is an intermediate clinical endpoint?
Likewise, an intermediate clinical endpoint is
a measure of a therapeutic effect that is considered reasonably likely to predict the clinical benefit of a drug
, such as an effect on irreversible morbidity and mortality (IMM).
What is an example of an endpoint?
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.
Are endpoints and outcomes the same?
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).
What is endpoint type?
Endpoint Information: Endpoint is where the service can be accessed by a client application. Endpoint Type:
Direct Address
.
SOAP URL
. Connect URL.
How do you find the endpoint?
Given the starting point, A , and the midpoint, B , draw the line segment that connects the two. Draw a line going farther from B away from A to God-knows-where. Measure the distance from A to B and mark the same distance from B going the other way.
The point you marked is the endpoint you
seek.
Which of the following are benefits of overall survival as a clinical trial endpoint?
Overall survival offers
the greatest clinical gain, provided that quality of life (qol) is not compromised
. As an endpoint, os is easily measured, unambiguous, objective, felt to be clinically significant, and unaffected by the timing of assessment.
What are the different phases of drug trials?
Phase I trials test
if a new treatment is safe and look for the best way to give the treatment. Doctors also look for signs that cancer responds to the new treatment. Phase II trials test if one type of cancer responds to the new treatment. Phase III trials test if a new treatment is better than a standard treatment.
What are exploratory objectives in clinical trials?
The objective is
to answer precise questions which condition the continuation or suspension of the drug’s development program
. Exploratory trials include a small number of patients or healthy subjects and expose them (over a short period of time) to a low dose of an investigational medicinal product.
Can you have two primary endpoints?
The term used in this guidance to describe this circumstance of multiple primary endpoints is
co-primary endpoints
. Multiple primary endpoints become co-primary endpoints when it is necessary to demonstrate an effect on each of the endpoints to conclude that a drug is effective.
How many secondary endpoints are there?
Only 1-2 major secondary endpoints
. Major secondary outcomes should be limited to 1-2 outcomes, which are intimately related to the primary outcome and to the general hypothesis being tested. Limiting the number of major secondary endpoints ensures that they are truly of central importance.
When do you use a composite endpoint?
When to Use Composite Endpoints.
When a study has a fairly rare endpoint
, it’s common to use a composite endpoint instead. Rare events may require a very large, expensive trial in order to get statistically significant results.
What is a medical endpoint?
Endpoint, Outcome Measure. In a clinical trial,
an outcome or event used to objectively measure the effect of a drug or other intervention being studied
. Common endpoints include severe toxicity, relief of symptoms, and improvements in quality of life. Clinical Trial.
What is a key secondary endpoint?
Key secondary endpoints are
those designated as most clinically important with pre-specified order for their analysis
. P-values and confidence intervals for all other analyses are presented with NO adjustment for multiplicity.
Why is primary endpoint important?
Primary endpoints
measure outcomes that will answer the primary or most important question being asked by a trial
, such as whether a new treatment is better at preventing disease-related death than the standard therapy
33
.
Why are composite outcomes used?
Why use composite outcomes in clinical trials? The main advantage of this approach is
increased statistical efficiency
. By measuring more than one result and combining the data in a single outcome, researchers have an easier time showing a statistically significant difference between the treatment group and controls.
What is a secondary outcome?
Full explanation: Secondary outcomes are
outcomes measured in studies or systematic reviews of treatment effects that are pre-specified in the protocol as being relevant
, but less important than the primary outcomes.
What is composite analysis?
Composite analysis involves
collecting large numbers of cases of a given meteorological phenomenon
. … The composite analysis then generally involves computing the composite mean and perhaps computing some other statistical measures, such as the standard deviation and statistical significance.
What is a composite summary?
Summary scores
combine many measures into one “overall” score
, even though the individual measures may address quite different aspects of quality. While composites include a few measures that are highly related, a summary score reflects many more measures that may address different issues.
What is composite mortality?
Composite mortality tables means
mortality tables with rates of mortality that do not distinguish between smokers and nonsmokers
.
Are secondary endpoints powered?
Secondary endpoints are
usually not taken into consideration
from a power or randomization standpoint when designing a trial; they are usually analyzed post-hoc. As they are not taken into consideration when designing the trial, secondary endpoints may not be statistically sound and should be interpreted with caution.
Can secondary endpoints be statistically significant?
Secondary endpoints
cannot be validly analyzed
if the primary endpoint does not demonstrate clear statistical significance. Control Clin Trials.
