In a clinical trial, the investigators must specify inclusion and exclusion criteria for participation in the study.
Inclusion and exclusion criteria define the characteristics that prospective subjects must have if they are to be included in a study.
Although there is some unclarity concerning the distinction between the two, the ICH E3 guideline on reporting clinical studies suggests that Poorly Justified Reasons for Exclusion:[1] Strongly Justified Reasons for Exclusion:[1] Potentially Justified Reasons for Exclusion[1] Coronary Heart Disease[2] Include criteria: Exclude criteria: A lesser studied form of exclusion criteria involves an absence of racial, ethnic, or sexual diversity that results in clinical trials that do not reflect the US population.
A recent systematic review of the literature of hearing loss in adults, while representative of the US population in terms of sex, does not adequately represent racial or ethnic diversity.
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