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Published on: September 20, 2019
Why do healthy volunteers participate in clinical trials?
Thijs van Iersel1, Jelle Klein2, Timothy C Hardman3
1ICON, Groningen, the Netherlands.
Aim:
To better understand the motivations and needs of healthy volunteers in clinical trials.
Methods:
The European Federation for Exploratory Medicines Development (EUFEMED) devised a Survey of 58 questions on motivations of volunteers to participate, as well as on needs at the level of convenience, risk/benefit, social interaction, partnership and altruism. The Survey was shared with European Clinical Research Units (CRUs) who agreed to conduct the Survey in volunteers taking part in their phase 1 trials.
Results:
The Survey generated responses from 4349 healthy volunteers. In 54% (95% CI: 52,55) of cases contributing to new treatments was the primary motivation to participate, vs. monetary compensation in 41% (95% CI: 39,42) of responders. Volunteer requirements during overnight stays defined as important were well-functioning showers (89%, 95% CI: 87,90), ability to spend some time outside (78%, 95% CI: 76,80), the meal quality (76%, 95% CI 73,78), access to high-speed internet (73%, 95% CI: 71,75), a place to read/work alone (69%, 95% CI: 66,71) and a good night rest (69%, 95% CI: 67,71). The opportunity to socialize with staff was important for 85% (95% CI: 83,87), a unit with a cozy interior for 70% (95% CI 67,72) and socializing with other participants for 63% (95% CI 61,66) of responders.
Conclusion:
Healthy volunteers in clinical trials have specific needs during their stay in the Clinical Research Unit. Volunteer recruitment, compliance and retainment, as well as an ethical and a subject-centric approach to trial design and conduct can benefit from understanding these needs.
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