Workshop on Excluded Older People from Clinical Research

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.

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.

As a result, study participants often did not represent the average patient in daily practice and the consequence is that many of medical decisions for older people are now extrapolated from clinical trial data derived from younger population. Medicines are often prescribed to older patients with very little idea of efficacy, dosage or adverse effects.

Moreover, older people require particular attention when a drug treatment is prescribed. 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.

Many of 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
• Specific diseases which are specific to older people
• Differences in pharmacokinetics and pharmacodynamics compared to other adults
• 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.  

Plase find the programm here.