Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry · SOCIAL QUESTIONS|health|illness|cancer

    #690628

    IATE #3648509
    anailís ar fhoghrúpa Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    subgroup analysis | subgroup analyses
    en
    Definition analysis of a subset of a clinical trial population defined by one or more intrinsic and extrinsic factors of the patients under investigation, usually measured at baseline (i.e. of a subgroup) Reference "COM-Terminology Coordination, based on: EMA. 'Guideline on the investigation of subgroups in confirmatory clinical trials' (26.11.2024). 31 January 2019 EMA/CHMP/539146/2013"
    Comment Not to be confused with 'sub-population', which is usually used to refer to a subset of the patient population described in the targeted therapeutic indication. Examples of subgroups include demographic characteristics (including genetic or other biomarkers), disease characteristics (including severity or (pheno)type of disease), environmental aspects, and clinical considerations (e.g. use of concomitant medication), region or centre.