Europe Gets Serious About Geriatric Trials

Much has been said over the past decade or more about the need to involve the elderly more closely in clinical research, but very little has actually changed. Now the European Forum for GCP has announced its determination to act on the issue.

“Older people are under-represented in clinical trials,” notes an EFGCP statement issued on 27 April 2012. “The absence of proper recruitment or the insufficient presence of older people in clinical development plans of new medicinal products is a fact for products not specifically devoted to ageing populations.”

The EFGCP Geriatric Medicine Working Party has developed a draft proposal for guidance on medical research with, and for, older people. The document provides recommendations on various ethical aspects of clinical trials performed in older people. The group hopes this will contribute to the protection of all older people when they become vulnerable patients in clinical trials and a better inclusion rate of this population.

The document makes recommendations about the ethical aspects of trials in older people, which it defines as those aged over 75. Older people experience a higher incidence of disease-related morbidities, take more medicines, are subject to more multiple medication regimens, and account for more drug-related adverse events than their younger counterparts, so it is important to improve knowledge, understanding and management of their conditions and treatment, according to the document.

EFGCP has requested comments on the draft proposal by 15 May 2012. It wants everybody to consider the following questions: which aspects of the guidance document would you agree with and support? Which aspects of the document would you disagree with and not support? Which aspects do you believe are missing or not fully addressed?

Feedback should be sent by email to geriatric-research-guidelines@efgcp.eu. Comments will be reviewed by the working party and discussed at a Workshop hosted by the University College of London on 11 June 2012.

“Help us raise awareness about this initiative!” urges the EFGCP in its statement. “Should you know of someone who works on this topic and could be interested in the workshop, please feel free to spread the information. Word of mouth is definitely the best ally to involve as many stakeholders as possible.”

The main aim of the London workshop is to finalize and publish the guidance document. For further details, go to www.efgcp.eu or contact the organizers’ Brussels office by phone on +32 2 732 87 83 or by e-mail at .