Applied Clinical Trials
European forum tackles the problem of limited elderly patients involved in clinical trials.
The European Forum for Good Clinical Practice (EFGCP) is stepping up its efforts to involve more older people in clinical research by focusing on two central questions: What can be done about it? What are the problems and the solutions?
There’s an urgent need to obtain better evidence for future treatment of older people (i.e., over 75) and for providing them with optimal care, according to Florian von Raison, MD, and Laurence Hugonot-Diener, MD, the co-chairpersons of the EFGCP’s Geriatrics Medicine Working Party in Brussels.
“There is only weak evidence-based guidance coming from often poor and insufficient clinical research, and this vulnerable population is often underrepresented in research and the development of drugs,” they noted in a statement issued in advance of the late September workshop on the topic, to be held in Nice, France. “If study participants do not represent the average patient in daily practice, the consequence is that many medical decisions for older people are extrapolated from clinical trial data derived from younger population.”
Drugs are often prescribed to older patients with very little idea of efficacy, dosage, or adverse effects, they believe. Global evaluation of their needs and frailtiesâ including co-morbidity, polypharmacy, disability, and cognitive impairment, is necessary in order to reduce the risk of a drug’s inappropriate use and to evaluate the chances of benefit, the risks of harm, and the cost-effectiveness of treatments.
Three years on from the EFGCP’s publication of detailed guidelines on older people and research, the organizers are keen for everybody to take a fresh look at this subject. Raison thinks several key areas of ethical concern in geriatrics remain:
âThe aim of the Nice event is to clarify definitions, identify issues, and find possible solutions in order to allow a comprehensive geriatric assessment in future research and regulatory measures. This will include the contributions from up to 10 emerging researchers. Following the postponement of the EFGCP workshop about “Excluded Older People from Clinical Research,” which was to be held in March 2015 in Barcelona, Spain, the organizers want to regain lost momentum.
The Geriatrics Medicine Working Party comprises a multi-stakeholder forum involving European members from academia, regulatory bodies, and the pharmaceutical industry and patient groups. It focuses specifically on social aspects (present and future healthcare of elderly populations), medical issues (the need for appropriately studied and labelled medicines, with particular attention to avoiding iatrogenic problems), and ethical concerns (ensuring appropriate healthcare and research protection for older people).
The group’s prime goal is to examine issues in the development of geriatric medicines that include approaches taken by ethics committees, information on medicines, and medical research provided to elderly patients, informed consent in elderly populations, new regulatory approaches, specific pharmaceutical formulations, and strategic approaches to educating society.
The EFGCP workshop will take place on September 27 at the Institut Claude Pompidou in Nice, and is being organized in partnership with Innovation Alzheimer.