A major step for Clinical Trials

In France, the conduct of clinical trials requires a prior express favourable opinion of a Committee for the protection of the persons, in French Comité de protection des personnes (CPP).

The competent CPPs have been designated randomly, by means of a draw since a law of 2012, implemented in November 2016. However, the random designation did not take into account the workload of the CPPs or the skills of their members, which contributed to difficulties and delays.

The AFPT – Club Phase 1 had participated with France Biotech, AFCROs and DITEP in the writting of the open letter of 17 December 2017 to alert the Minister of Health to the necessity of reforming the process for the selection of CPPs.

Therefore, the AFPT – Club Phase 1 welcomes the adoption of the new Law No. 2018-892 of 17 October 2018 which stipulates that the CPP will now be randomly drawn among the committees available and with the required skills for the project review. This marks a major step towards improving the competitiveness of France in Clinical Trials.

Read the press release from France Biotech here

 

Réaction du Club Phase 1 à la lecture des informations et du protocole de l’essai clinique du BIA 10-2474 publié par l’ANSM