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Endpoint
Endpoint An indicator measured in a subject or biological sample to assess the safety, efficacy, or other objective of a trial. See also surrogate marker.
RELATED TERMS--------------------------------------
Safety
relative freedom from harm; in clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests and procedures, psychiatric evaluation, and/or physical examination of subjects.
Surrogate
A substitute.
SIMILAR TERMS--------------------------------------
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Erythropoiesis
The formation of red blood cells.
Exanthema
A skin eruption occurring as a symptom of an acute viral or coccal disease, as in scarlet fever or measles.
Extracellular
Outside the cells.
Extraocular
Adjacent to but outside the eyeball.
Entire trial
Also called parallel group trial, parallel design trial.
Endpoint
Equipoise
A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient. An investigator who has a treatment preference or finds out that one arm of a comparative trial offers a clinically therapeutic advantage should disclose this information to subjects participating in the trial. Ethically, subjects should only be entered or continue in a trial where equipoise exists for that subject.
Equivalence trial
A trial with the primary objective of showing that the response to two or more treatments differs by an amount which is clinically unimportant. This is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence level of clinically acceptable differences.
Ethics approval
The affirmation decision of the ethics committee that the clinical trial has been independently reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements.
Ethics committee (EC)
an independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations, and regulatory requirements pertaining to independent ethics committees may differ among countries, but should allow the independent ethics committee to act in agreement with GCP as described in the ICH guideline. See also institutional review board.
Exclusion criteria
A list of criteria, any one of which excludes a potential subject from participation in a study. See also inclusion criteria, admission criteria.
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