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 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 .
What is a primary endpoint in a study?
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 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.
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?
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 does study endpoint mean?
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 is the difference between primary and secondary outcomes?
The primary outcome is the variable that is the most relevant to answer the research question. ... Secondary outcomes are additional outcomes monitored to help interpret the results of the primary outcome: in our example, an increase in the 6MWD is inversely associated with the need for lung transplantation.
What is a supportive secondary endpoint?
Secondary endpoints are those that may provide supportive information about a drug’s effect on the primary endpoint or demonstrate additional effects on the disease or condition.
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] ...
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.
What is a tertiary endpoint?
Tertiary endpoints typically capture outcomes that occur less frequently , or which may be useful for exploring novel hypotheses.
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.
What is primary safety endpoint?
Primary safety endpoint: A composite of major adverse events (MAE) comprising death , any major amputation performed on the target limb or clinically-driven target lesion revascularization (TLR) through 30 days.
What is primary efficacy endpoint?
The primary efficacy endpoint in a clinical trial is a clinical or laboratory outcome measured in an individual after randomization that allows one to test the primary hypothesis and provides the means of assessing whether a therapy is effective compared with its control .
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.
