2023-08-16 16:00:06
This article is sure to grab the attention of readers of Nature Medicine of August 14. Alongside the publications of research results, this “correspondence” speaks of healthy volunteers enrolled in clinical trials as “professional guinea pigs”, some participants in several studies simultaneously, to the point of compromising their health and the validity of these trials. Signed by nine personalities from medical research from all over the world (France, United States, South Africa, Malaysia, Argentina, etc.), this forum relays an initiative to establish a code of good conduct. The objective is to distinguish the status of volunteers without pathology, who take part in a trial most often for financial reasons, from that of patients who hope for a therapeutic benefit.
A highly competitive global market
The initiative, dubbed “VolREthics” (for volunteers in research and ethics), was launched by the National Institute of Health and Medical Research (Inserm) in February 2022, at the end of the Covid-19 pandemic. The rapidity of bringing vaccines to market had only been possible thanks to “vaccine challenges” in which volunteers agreed to receive a vaccine of which little was known before being confronted with a virus that we knew was uncontrollable.
Behind these heroes of the pandemic who took risks for the benefit of the greatest number hides a little-known industry, that of CRO (contract research organization) or contract research companies. On behalf of pharmaceutical laboratories, these service providers recruit volunteers, pay them, organize the trials and validate their results. This market has become global and very competitive. “CROs are constantly striving to speed up timelines and reduce costs, which can lead to more aggressive recruitment processes and might lead to compromises on ethical standards”write the signatories of the forum.
In eighteen months, two plenary meetings, one in Paris under the aegis of Unesco, the other in Brussels under that of the European Commission, and one regional meeting per continent, VolREthics has mobilized several hundred people from pharmacy, government agencies, academic research, and even CROs and a few volunteers.
Three working groups (protect once morest the risk of exploitation of volunteers, protect once morest the risk of harm, guarantee the validity of studies) launched in July should lead to the drafting, from the beginning of 2024, of a code of good behavior. It will have no coercive power, even if the World Health Organization (WHO), the Council for International Organizations of Medical Sciences (founded by WHO and Unesco) or even the partnership of European and development on clinical trials have joined the adventure.
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