Applied Clinical Trials
A major European congress looks set to focus attention on the growing campaign for more participation of the elderly in clinical trials.
The European Forum for GCP (EFGCP) is holding a two-day meeting in Brussels, Belgium, later this month that will seek to answer a single question: Is Europe ready to cope with the challenge of an aging population for medical research?
By around 2030, over one-third of Europe's population will be age 65 or older. But the Silver Tsunami has already hit the shores of Europe and will have major implications for drug development that have not so far been fully recognized, according to the meeting's organizers.
The EFGCP's Geriatric Medicines Working Party has voiced concerns about the exclusion of many older people from medical research, as well as the need to study particular diseases and develop specific medications for this population. It is keen to provide practical advice for all those involved in clinical research and learn the lessons from other specific populations to aid and highlight strategies that will benefit the elderly.
"The ethical issues surrounding research experimentation in this population has also only been explored superficially, and to date there has been little recognition within the ethical medical, regulatory bodies or the political fields of the extent this markedly changing demography will have on the requirements of medical research," noted a Working Party document.
Many clinical studies focusing on efficacy and safety have age cut-offs that limit their applicability to older people, many of whom suffer from extensive multiple morbidities and increasingly consume an array of drugs. Instead, first-in-man studies are often carried out in fit young men who have vastly different pharmacodynamic and pharmacokinetic characteristics from the older patient populations, predominantly females.
For its Brussels congress on November 19 and 20, EFGCP is bringing together experts in clinical research, ethics, philosophy, social and patient organizations, and regulatory affairs to explore the issues surrounding the impact of the demographic transition.
Another group promoting discussion of this issue is the EU-funded PREDICT (Increasing the PaRticipation of the ElDerly In Clinical Trials) project. It is working on the third draft of its charter for trials in the elderly, which is due to be unveiled in London on February 1, 2010 (see Global News, Applied Clinical Trials, June 2009).
It is making modifications following feedback from health professionals and patient representatives in nine European countries. It has also decided to prepare a separate version of the charter for the lay public.
"In our survey of health professionals, there was a strong consensus that under-representation caused difficulties for prescribers and patients, and that exclusion from clinical trials on grounds of age alone is unjustified," said Project Manager Judith Sinclair-Cohen, BDS, MSc. "The vast majority of respondents also felt that people with co-morbidities should not be excluded in protocols."
Older people feel it is important to be invited to take part in trials, and information must be clear and understandable. Also, they think additional practical support should be given to some older subjects, and trials should evaluate quality of life, not just survival from an illness.
Older people are keen to take part in clinical trials that they consider to be risky yet worthwhile, and research can focus specifically on older people, Sinclair-Cohen noted.
For more details about EFGCP's Brussels conference, visit www.efgcp.be—Philip Ward