Problems and solutions with the elderly in clinical trials

07 May 2014
09:25 - 09:50
Chair person  Anne-Laure Tardy
Speaker(s)  Annegret Auinger

Although representing a part of the general population, the elderly are a very interesting group of people in our modern society. They have a particularly strong wish to stay fit and healthy in order to avoid having to depend on help by others, they are economically able and willing to buy health products, and represent a population at risk for developing diseases more than many others in the general population.

However, people of the elderly generation often present with impairments, physical and mental weaknesses, that can cause problems when running clinical trials. A&r as a CRO strategically decided to put a particular awareness to their needs, which allowed us to gain a lot of experience with this population, which we would like to share in this presentation. Knowing about the shortcommings of working with the elderly in clinical trials, we have adapted our logistics and other means to their special needs. This has put us as a CRO in a position able to recruit and work with a wonderful population at risk for many health issues.

F.e. setting the right inclusion and exclusion criteria for a clinical trial can be of utmost importance in order to produce significant outcomes. The handling to products may well be an issue for the elderly, not just in clinical trials but also for winning a greater acceptance for a product delivery format.

Examples of positive evaluations of health claim applications by EFSA exist that we would like to highlight in discuss. We have examined these applications and will share our conclusions in regards to clinical trial designs.

Who Should Attend and why:

Colleagues who are developing health products for the elderly population should attend this talk. Particularly clinical scientists, medical advisers and regualtory operators which ar involved in running and evaluating clinical trials with the elderly population.

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