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 does endpoint mean in a 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.
What are primary and secondary endpoints in a study?
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 is a primary endpoint example?
A primary endpoint is the main measurement a trial is trying to assess . It answers the most important question in the trial. For example: In a weight loss study: What is the average weight loss after six months?
What is a secondary endpoint in a study?
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 .
Can a study have 2 primary endpoints?
Co-primary endpoints should only be used when there are more than one primary endpoint and declare the study success only if both primary endpoints are statistically significant in favor of the experimental treatment. When co-primary endpoints are used, each primary endpoint is tested at significant level of 0.05.
Can a study have multiple primary endpoints?
Multiple endpoints. Multiple endpoints can be chosen and evaluated separately , such that a significant treatment effect against any one of the endpoints may be taken as evidence of efficacy. ... Multiple primary endpoints become ‘co-primary’ if an effect on multiple outcomes is required to demonstrate proof of efficacy [3] ...
Is endpoint and outcome 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 the difference between objective and endpoint?
The endpoints (or outcomes), determined for each study participant, are the quantitative measurements required by the objectives. ... Clinical trials typically have a primary objective or endpoint. Additional objectives and endpoints are secondary . The sample size calculation is based on the primary endpoint.
What does endpoint mean?
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.
Is primary outcome the same as primary 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).
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 tertiary endpoint?
Tertiary endpoints typically capture outcomes that occur less frequently , or which may be useful for exploring novel hypotheses.
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.
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.
Why are endpoints used?
An endpoint is the primary outcome that is being measured by a clinical trial . A cancer drug, for example, might use survival as an endpoint, comparing the five-year survival rate of patients using an experimental therapy against the five-year survival rate of patients using another treatment or a placebo.
