Frailty: evaluation instruments for baseline characterisation of clinical trial populations

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Reference numberEMA/CHMP/778709/2015
Published21/12/2015
KeywordsFrailty, older people, ICH E7, geriatrics, elderly, baseline characterisation, ageing
DescriptionThese document provides guidance for the evaluation of the baseline frailty status of patients (typically, but not exclusively aged > 65 yrs.) enrolled in a clinical trial or other clinical investigation (e.g. registry). It supplements the requirements of ICH E7 Questions and answers.


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