Simple test could increase number of elderly subjects in clinical trials, says EMA
The test assesses lower-extremity function, which can indicate the general frailty of a subject
The use of simple physical tests to assess frailty in older clinical trial subjects can be an effective way to measure the likelihood of a patient having a positive response to medicine, a European Medicines Agency (EMA) assessment has concluded.
A discussion paper entitled: ‘Points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial populations', highlights the potential of the Short Physical Performance Battery (SPPB) test.
This test assesses lower-extremity function through testing standing balance, walking speed, and ability to rise from a chair. Such a check can indicate the general frailty of a subject, says the paper. 'Physical performance measures in general, appear to integrate the effects of multiple facets of health and ageing, including disease processes nutritional status, fitness, and emotional state,' it said.
Armed with such knowledge, a pharmaceutical company could perhaps feel more confident about measuring the impact of a medicine on older patients, increasing their number in clinical trials. The paper noted that this was important: 'Older persons are large drugs consumers for a number of chronic diseases, but despite this they have often been excluded from clinical trials,' it said.
The paper added: 'Better characterisation of this growing segment of the population, following a standardised approach, might also help the evaluation of efficacy and safety of drugs in the post authorisation phase.'