Companies Dive Into French Stress Test Of Future EU Trial Procedures
This article was originally published in SRA
The French regulator ANSM says that pharmaceutical companies and ethics committees have shown keen interest in its pilot project intended to test how the clinical trial application process will work under the EU's Clinical Trials Regulation, with 11% of all trial applications being filed within the framework during its first six months1.
Reflecting the future requirements of the CTR, the French pilot called for a single notification to the sponsor comprising the opinion of both the ANSM and the ethics committee2. The aim was to allow companies and other players to familiarize themselves with the new procedures that the regulation will impose and to see how best to ensure proper coordination between ANSM and the ethics committees.
A total of 51 applications were filed under the pilot, out of a total of 465 received by ANSM and the ethics committees over the period from Sept. 28, 2015, to March 28, 2016, ANSM said in a review of the project. 33 of the applications were filed by commercial companies and 18 by academic sponsors.
The largest number of applications (17) concerned Phase III trials, followed by Phase I (15), Phase II (13) and Phase IV (6). By the end of the pilot, 26 of the application procedures had been completed, 15 of them filed by companies and 11 by academics. Of these 26, a total of 21 resulted in an approval by ANSM and a favorable opinion from the ethics committee concerned.
The average time to final approval for the trial to go ahead was 57.4 days (the current regulations stipulate a maximum 60-day timeline). Overall, said ANSM, the various timelines were respected at each stage of the evaluation and approval process (acceptance of the application, list of questions, final notification).
The pilot enjoyed wide participation of stakeholders and helped to strengthen relations and improve dialogue among them, ANSM said, noting that 21 of the 39 French ethics committees took part in the pilot. Progress with the application dossier could be followed clearly at all stages. The end result was "good preparation for the future constraints of the evaluation calendar," ANSM observed.
Following these initial results, ANSM said it would continue to encourage stakeholders to follow the new procedures, which would remain available until the provisions of the CTR take effect (now expected in autumn 20183).
It said it would also be updating its "Practical Information Guide for Applicants," particularly with regard to the "Day 45" deadline for replies to questions posed by ANSM and/or the ethics committee. The new version will be published shortly on the agency's website.
The CTR
Under the CTR, requests for clinical trial approval in more than one EU member state will be evaluated centrally under a coordinated EU procedure. The sponsor will submit a single application via the new clinical trials portal, and the information in the application will be logged onto a database.
In the first stage of the trial authorization application procedure, the member states concerned will conduct a co-ordinated evaluation that results in a single decision, after which each country will reach a national decision on trial go-ahead.
References
- ANSM, Update on pilot project, April 11, 2016, http://ansm.sante.fr/S-informer/Actualite/Mise-en-application-du-reglement-europeen-relatif-aux-essais-cliniques-de-medicaments-bilan-a-six-mois-de-la-phase-pilote-Point-d-information
- French To Test Future EU Clinical Trial Procedures For Drugs, Scrip Regulatory Affairs, Oct. 6, 2015
- Elusive EU Clinical Trial Rules Slip Again – This Time To Late 2018, Scrip Regulatory Affairs, Dec. 22, 2015