Europe Turns Spotlight on Geriatric Trials

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-06-01-2012, Volume 21, Issue 6

The European Forum for GCP (EFGCP) is determined to achieve significant progress involving the elderly more closely in clinical research.

The European Forum for GCP (EFGCP) is determined to achieve significant progress involving the elderly more closely in clinical research.

"Older people are under-represented in clinical trials," noted an EFGCP statement issued at the end of April. "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 aging 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 seniors. The group hopes this will contribute to the protection of all elders 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 requested comments on the draft proposal by May 15, 2012. It asked clinical researchers 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? Comments will be reviewed by the working party and discussed at a workshop hosted by the University College of London on June 11, 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 goal 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 conferences@efgcp.eu.

Overall, this initiative aims to build on the work of the PREDICT project (www.predicteu.org), which stands for increasing the PaRticipation of the ElDerly in Clinical Trials.

Funded by the European Union and coordinated by the Medical Economics and Research Center in Sheffield, UK, its members consisted mainly of European geriatricians who were concerned that they were often unable to prescribe the best course of treatment due to insufficient scientific evidence from clinical trials. Often clinicians are left to extrapolate from studies of younger, healthier subjects—a practice fraught with difficulty, they warned.

PREDICT began in February 2008, and ran for 27 months. It produced a charter designed "to effect a paradigm shift" by engaging both the stakeholders of older people's health and the gatekeepers of clinical trials. Potential solutions were also addressed.

—Philip Ward