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.
For more information and the reflection paper please click here:
> European Medicines Agency (article)
> Reflection paper (PDF)