Baseline frailty evaluation in drug development

A standardized characterization of frailty is potentially useful for risk stratification and to improve the description of the characteristics of older populations involved in clinical trials or post- authorization registries. If such frailty scales were to be routinely introduced to characterize baseline demographics of the population enrolled in a clinical trial for a drug with highly prevalent use in the older population, this might encourage active inclusion of frail patients thereby enhancing the assessment of the benefit/risk balance of the product in target ‘real world’ population