Clinical Research Endpoint

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A Clinical Research Endpoint is a clinical outcome measure used in a clinical trial to determine the efficacy and safety of the therapy being studied.



  • (Wikipedia, 2021) ⇒ Retrieved:2021-11-8.
    • Clinical endpoints or clinical outcomes are outcome measures referring to occurrence of disease, symptom, sign or laboratory abnormality constituting a target outcome in clinical research trials. The term may also refer to any disease or sign that strongly motivates withdrawal of an individual or entity from the trial, then often termed a humane (clinical) endpoint.

      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.

      Surrogate endpoints are trial endpoints that have outcomes that substitute for a clinical endpoint, often because studying the clinical endpoint is difficult, for example using an increase in blood pressure as a surrogate for death by cardiovascular disease, where strong evidence of a causal link exists.


  • (Wikipedia, 2021) ⇒ Retrieved:2021-11-15.
    • In a general sense, a clinical endpoint is included in the entities of interest in a trial. The results of a clinical trial generally indicate the number of people enrolled who reached the pre-determined clinical endpoint during the study interval compared with the overall number of people who were enrolled. Once a patient reaches the endpoint, he or she is generally excluded from further experimental intervention (the origin of the term endpoint).

      For example, a clinical trial investigating the ability of a medication to prevent heart attack might use chest pain as a clinical endpoint. Any patient enrolled in the trial who develops chest pain over the course of the trial, then, would be counted as having reached that clinical endpoint. The results would ultimately reflect the fraction of patients who reached the endpoint of having developed chest pain, compared with the overall number of people enrolled.

      When an experiment involves a control group, the proportion of individuals who reach the clinical endpoint after an intervention is compared with the proportion of individuals in the control group who reached the same clinical endpoint, reflecting the ability of the intervention to prevent the endpoint in question.

      A clinical trial will usually define or specify a primary endpoint as a measure that will be considered success of the therapy being trialled (e.g. in justifying a marketing approval). The primary endpoint might be a statistically significant improvement in overall survival (OS). A trial might also define one or more secondary endpoints such as progression-free-survival (PFS) that will be measured and are expected to be met. A trial might also define exploratory endpoints that are less likely to be met.


    • QUOTE: ... An endpoint is a targeted outcome of a clinical trial that is statistically analyzed to help determine the efficacy and safety of the therapy being studied. Endpoints for a clincial trial may include one or more clinical outcome assessment and/or surrogate endpoint. Clinical outcomes assessments measure direct clinical benefit to the participant where as surrogate endpoints, including biomarkers, predict clinical benefit. Endpoints may also be used to throughout a study to determine if a participant’s risk of continuing to be in a study is too great.

      Endpoints must be validated prior to using in a clinical trial. Endpoint choice depends on the clinical trial design, the nature of the disorder or condition being treated, and the expected effect of the therapy being tested. Chosen endpoints are usually clearly defined prior to the start of a clinical trial. A clinical study may have one or more primary, secondary, and exploratory endpoints. Primary endpoints will be the basis for determining whether the study met its objective or, in the case of interventional clincal trials, will be the main data evaluated for regulatory approval. Secondary endpoints are those that may provide supportive information about a therapy’s effect on the primary endpoint or demonstrate additional effects on the disease or condition. 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. ...