BASELINE FRAILTY EVALUATION IN DRUG DEVELOPMENT

Abstract

Older people are high consumers of medicines, but despite this they have often been excluded from clinical trials. Reasons for exclusion have frequently been poorly justifiable, and have included predefined arbitrary upper age limits, lists of different comorbidities, polypharmacy or physician/patient/family preference. This selection bias is even more evident for the frail older adults. Consequently, the evidence base in this age group is often limited at the time of market authorisation. The benefit/risk analysis for the frail older adult may well be different from that of younger people, and a lack of data may result in inappropriate prescribing.