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

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 PDF icon ICH E7 note for guidance and questions and answers.

Keywords: Frailty, older people, ICH E7, geriatrics, elderly, baseline characterisation, ageing

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