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The European Forum for GCP (EFGCP) Geriatric Medicines Working Party is organizing a multi-stakeholder workshop, “Excluded Older People from Clinical Research”
The European Forum for GCP (EFGCP) Geriatric Medicines Working Party is organizing a multi-stakeholder workshop, “Excluded Older People from Clinical Research,” in Barcelona, Spain, on March 24, 2015.
In partnership with the Hospital Clínic and Faculty of Medicines in Barcelona, the event will ask two central questions: What can be done about it? What are the problems and the solutions?
“In spite of the ageing 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,” noted a release from EFGCP. “In other words, there is only weak evidence-based guidance coming from often poor and insufficient clinical research: this vulnerable population is today underrepresented in research and drug development.”
Many medical decisions for older people are now 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 EFGCP. Global evaluation of their needs and frailties, including co-morbidity, polypharmacy, disability, and cognitive impairment, is necessary to reduce the risk of a drug’s inappropriate use and weigh the chances of benefit, the risks of harm, and the cost-effectiveness of drug treatments.
Among the areas of ethical concern in geriatrics are: different reaction to medicines from other adults, issues of information and consent (due to mental deterioration), involvement of family and carers; appropriate age-relevant formulations, diseases which are specific to older people, differences in pharmacokinetics and pharmacodynamics compared to other adults, and complicated diagnosis (need for a comprehensive geriatric assessment).
“The objective of this workshop is 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,” stated the organizers.
You can read the full announcement here.