New Clinical Trial Law is Great News for France
May 31, 2018
The French National Assembly's adoption of a new law reforming how trial ethics committees are selected is a major step forward for clinical research in France. Under the new law, announced in late May, ethics committee members will be selected based on their relevant experience while maintaining the goal to prevent conflicts of interest. This approach is intended to replace a completely random draw, which led to inefficiency and delays as selected members often had experience that did not correspond with the medical field of the study. According to a 2017 study conducted by the Boston Consulting Group, the inadequacy of the previous system resulted in 68% percent of French studies being conducted abroad.
This law follows the French National Agency for the Safety of Medicines and Health Products (ANSM)’s creation in December 2017 of a new organization by establishing the “Early Development Group” responsible for the evaluation of all Phase I protocols.
Fortunately with this new selection procedure in place, trial authorization timelines will be streamlined allowing France to recover its position as a research leader. Case in point: Biotrial just received ANSM approval for a Phase I, Healthy Volunteer trial in France within 26 days.
What does this mean for Biotrial and for our sponsors moving forward? Though we have always been committed to providing our sponsors with ultra-competitive timelines, including our work with first-to-file studies, our partnerships will be strengthened by these new favorable conditions in France.
Contact us to learn more and read the press release from France Biotech here.