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  ICH: E 7: Studies in support of special populations: Geriatrics: Questions and answers - Step 5.

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

Current effective version

Reflection paper on physical frailty: instruments for baseline characterisation of older populations in clinical trials - First version

AdoptedLegal effective date: 24/01/2018Reference Number: EMA/CHMP/778709/2015Summary:

This document is intended to describe the recommended instruments for the characterization of the baseline physical frailty status of older patients (i.e. aged ≥ 65 years) enrolled in a clinical trial or other clinical investigation (e.g. registry), to supplement the requirements of ICH E7 Note for guidance and questions and answers.

Document history

Reflection paper on physical frailty: instruments for baseline characterisation of older populations in clinical trials - First version

AdoptedLegal effective date: 24/01/2018Reference Number: EMA/CHMP/778709/2015Summary:

This document is intended to describe the recommended instruments for the characterization of the baseline physical frailty status of older patients (i.e. aged ≥ 65 years) enrolled in a clinical trial or other clinical investigation (e.g. registry), to supplement the requirements of ICH E7 Note for guidance and questions and answers.

Overview of comments on 'Points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial populations' (EMA/CHMP/778709/2015) - First version

Draft points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial populations - First version

Consultation dates: 21/12/2015 to 31/05/2016Draft: consultation closedReference Number: EMA/CHMP/778709/2015Summary:

Older persons are large drugs consumers for a number of chronic diseases, but despite this they have often been excluded from clinical trials.

Proposal for the development of points to consider for baseline characterisation of frailty status

Reference Number: EMA/335158/2013