EMA - Reflection paper on physical frailty

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

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.

Link to the article

PDF VERSION

20.03.2018