ANSM Says Pilot for New Clinical Trials Regulation Enforcement a Success
France's Agency Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) on Wednesday reported positive results for its year-long pilot for assessing clinical trials using the process established in the new EU Clinical Trials Regulation.
Background
In 2014, Regulation (EU) No. 536/2014, known as the new Clinical Trials Regulation, was adopted. The goal of the regulation is to provide faster, more coordinated assessments for clinical trial applications through a central portal. The regulation also promises to improve transparency through the publication of clinical trials via a public database.
While the Clinical Trials Regulation was initially expected to take effect in May 2016, the regulation is effectively delayed until the EU clinical trials portal and database are completed.
ANSM Pilot
In preparation for the Clinical Trials Regulation coming into effect, ANSM launched a voluntary pilot in September 2015 to simulate clinical trial application reviews under the new regulation.
In the pilot, which involved both academic and industrial clinical trials sponsors, ANSM sought to provide sponsors with a decision from the agency and corresponding ethics committee for clinical trials applications within 60 days.
According to ANSM, the pilot represented "positive progress for all concerned."
During the one year, ANSM says it received a total of 897 clinical trials applications. Of these, 112 (12.5%) were assessed as part of the pilot. ANSM also notes that the amount of clinical trials submitted to the pilot increased in the second half, with 51 submissions in the first six months and 61 submissions in the second six months.
| Sponsor Type | Trial Type | Trials Involving Research Centers | |||||
|---|---|---|---|---|---|---|---|---|
| Academic | Industrial | Phase I | Phase II | Phase III | Phase IV | National | International |
| First 6 Months | 18 | 33 | 15 | 13 | 17 | 6 | 19 | 32 |
| Full Year | 50 | 62 | 24 | 28 | 53 | 7 | 52 | 60 |
By the end of the pilot's first year, ANSM says it completed assessments for 89 of the 112 submissions it received. Of these, ANSM authorized 73 trials and rejected applications for 16, with an average time to notification of 64.3 days.
While this figure is slightly longer than the 60 days specified in the Clinical Trials Regulation, ANSM says that overall it was able to meet the time frames for each stage of the assessment process, and that "in the majority of cases one decision was returned within the deadline imposed by the current legislation."