Physical frailty: instruments for baseline characterisation of older populations in clinical trials - Scientific guideline
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The 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 
ICH E7 note for guidance and questions and answers.
Keywords: Frailty, older people, ICH E7, geriatrics, elderly, baseline characterisation, ageing
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Reflection paper on physical frailty: instruments for baseline characterisation of older populations in clinical trials - First version (PDF/955.29 KB)
Adopted
First published: 22/02/2018
Last updated: 22/02/2018
Legal effective date: 24/01/2018
EMA/CHMP/778709/2015 -
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Overview of comments on 'Points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial populations' (EMA/CHMP/778709/2015) - First version (PDF/510.46 KB)
First published: 22/02/2018
Last updated: 22/02/2018 -
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Draft points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial populations - First version (PDF/583.58 KB)
Draft: consultation closed
First published: 21/12/2015
Last updated: 21/12/2015
Consultation dates: 21/12/2015 to 31/05/2016
EMA/CHMP/778709/2015 -
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Proposal for the development of points to consider for baseline characterisation of frailty status (PDF/49.54 KB)
First published: 13/06/2013
Last updated: 13/06/2013
EMA/335158/2013
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