EFGCP Steps Up Campaign to Include Older People

What can be done to involve older people in clinical trials? What are the problems and the solutions? These are the main questions being addressed by the Geriatric Medicines Working Party of the European Forum for Good Clinical Practice (EFGCP).   “With an aging of the population worldwide, there is a significant gap to be filled in order to obtain better evidence for future treatment of older people and for providing them with optimal care. 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,” noted a statement released by the EFGCP.   Members of the working party are pushing ahead with organizing a multi-stakeholder workshop on “Technology, Ethics and Older People in Clinical Research.” The event will held on September 27th, 2016 at Institut Claude Pompidou, Nice, France, in partnership with Institut Claude Pompidou and Innovation Alzheimer.   Many medical decisions for older people are extrapolated from clinical trial data derived from younger population, and medicines are often prescribed to older patients with very little idea of efficacy, dosage or adverse effects, according to the workshop organizers.   “Global evaluation of their needs and frailties, including co-morbidity, polypharmacy, disability, and cognitive impairment, is necessary in order to reduce the risk of drug’s inappropriate use and appropriately weigh the chances of benefit, the risks of harm, and the cost-effectiveness of drug treatments. In addition the rapid development of technology is influencing many aspects of clinical research,” they stated.    Among the areas of ethical concern in geriatrics are the different reaction to medicines from other adults, issues of information and consent (due to mental deterioration), involvement of family and careers, appropriate age-relevant formulations, diseases that are specific to older people, differences in pharmacokinetics and pharmacodynamics compared to other adults, complicated diagnosis (need for a comprehensive geriatric assessment), and increasing ethical issues around technology.    The organizers are seeking to clarify definitions, to identify issues, and to find possible solutions in order to allow a comprehensive geriatric assessment in future research and regulatory measures, and this will include the contributions of up to 10 emerging researchers.   - Philip Ward