Baseline Frailty Evaluation in Drug Development

This ‘Points to Consider’ document provides a menu of validated and therefore recommended instruments. Individual instruments (or combinations) to characterize the baseline frailty status may be selected for a clinical development program, according to the therapeutic area and the PD profile of the medicinal product under investigation. In the absence of specific pharmacodynamic parameters of interest but a desire to broadly characterize baseline frailty with one instrument, the determination of physical frailty status by SPPB testing is the preferred option as it has a strong correlation to adverse outcomes including mortality, nursing home admission and subsequent disability. This menu is not exhaustive and other validated instruments may be more suitable in specific circumstances. The development and validation of alternative / additional scales to better characterize specific patient populations is encouraged. 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-authorisation 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 the target ‘real world’ population