Physical frailty: instruments for baseline characterisation of older populations in clinical trials

Current effective version

PDF iconReflection paper

Reference numberEMA/CHMP/778709/2015
Published22/02/2018
Effective from24/01/2018
KeywordsFrailty, older people, ICH E7, geriatrics, elderly, baseline characterisation, ageing
DescriptionThe reflection paper describes how to characterise the baseline frailty status of older patients enrolled in clinical trials other than by their age. The aim is to ensure that clinical trial populations are representative of the users of the medicine, as the benefit-risk balance in older patients may depend on their physical frailty status. This supplements the requirements of PDF iconICH E7 note for guidance and questions and answers .


Document history

First version

Current version

PDF iconReflection paper

PDF iconOverview of comments


PDF iconPoints to consider

PDF iconProposal for development of points to consider

In operation: 24/01/2018–present

Published: 18/09/2008

Published: 21/12/2015

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