The European Medicines Agency published a reflection paper on assessing the frailty of elderly patients in clinical trials, recommending the Short Physical Performance Battery assessment for its prognostic value and ease of use.
The agency noted the importance of gathering data on older patients in clinical development, as they are large consumers of medical products. Often they are excluded from clinical trials due to physical frailty. Although there is a general agreement on the concept of frailty, a standardized assessment instrument is still needed, the EMA said.
The EMA Geriatric Expert Group’s reflection paper examined several instruments for baseline characterization of physical frailty of patients aged 65 years and older enrolled in a clinical trial or other investigations, such as a registry. The instruments are proposed to supplement age as a demographic factor, to better support understanding of a product’s risk-benefit relationship in older populations.
Instruments were measured by their ability to predict disability and mortality, validation status, feasibility of use across therapeutic areas, time required, training requirements and cost.