Reflection paper on physical frailty approved by EMA


The reflexion paper on physical frailty is approved and published at the EMA website. 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. The reflection paper is available at this website: teaching/info/EMA and Geriatric Expert Group.