Clinical Trials Facilitation Group
EU Heads of Medicines Agency (HMA) agreed in 2004 to establish a clinical trials (CT) facilitation group (CTFG) to coordinate implementation of the "EU clinical trials directive" 2001/20 EC across the member states. This is a major step for the achievement of harmonization of CT in Europe. The CTFG is attended by representatives from the NCA's, European Commission and the European Medicines Agency.
In order to achieve and to implement this mandate CTFG has drafted a work plan for 2008-2009 which has the following ambitions and aims:
- Sharing of scientific assessment of multinational clinical trials
- Harmonizing processes and practices relating to clinical trials mainly in the fields of clinical trial applications (CTA), clinical trial amendments and safety procedures
- Developing data sharing and participating in the improvement of information systems
- Developing communication with stakeholders and co-operating with other EU working groups
The main objectives of the assessment of the CT are to ensure subjects' safety and IMP's quality and safety. A harmonization procedure for the assessment of MN-CT applications is proposed before the initial phase of the national process and, on the voluntary basis.
In the context of the implementation of directive 2001/20/EC, and with the aim to harmonize the conduct of clinical trials within EU Member States (MS), the EU-commission has issued detailed guidance and information regarding major aspect of clinical trials.
The Voluntary Harmonization Procedure (VHP) is offered in a pilot phase for clinical trials meeting the following criteria:
- MN-CTs involving an IMP without marketing authorization in the EU
and any of the following :
- First in Human MN-CTs and particularly with investigational medicinal products with known or anticipated risk factors as described in EMEA/CHMP/SWP/2836707/2007.
- MN-CTs with "Critical" investigational medicinal products (limited community expertise e.g. IMP with novel modes of action, novel manufacturing process, novel administration and storage requirements, links to a class of medicinal product with recognized safety concerns, unresolved pre-clinical abnormal findings, for instance monoclonal interfering with immune regulation, advanced therapies) or "Critical" MN-CTs (e.g. for limited trial populations e.g. orphan diseases, less common types of cancer, pediatrics diseases with small numbers, adult diseases with small numbers or unmet medical needs), based on NCA's judgment, endorsed by the CTFG.
- MN-CTs with very large population and where the sponsor indicates a need for harmonization (e.g. large phase III CTs and several 5-10 MS concerned).
The VHP will be comprised of three phases that consist of a "pre-procedural" or "request for a VHP", a review of a draft CTA by the NCAs of the participating member states, and a national step by the National competent authorities concerned.
During the first phase, the applicant should describe the key features of the CT together with the CT protocol synopsis. Within 5 days after the TC, the VHP-Coordinator informs the applicant of the CTFG decision regarding the acceptance of the CTA in the VHP.
After the VHP, a national Clinical Trial Application has to be filled by the sponsor according to the national laws for the approval of clinical trials. In the case of the positive VHP statement by the Member State(s) a national approval should not take longer than 10 days, after the submission of a valid application. Regarding the VHP assessment step II, the revised version of the draft CTA is considered approvable by all P-NCAs on 50 days and more if is considered as not approvable.
Regarding the "national step" / CTA, the submissions of the CTA at the national levels should be no later than 20 days after receipt of the CHP acceptability statement by the applicant.
More information on the VHP can be found in the Guidance document for a Voluntary Harmonization Procedure (VHP) for the assessment of multinational Clinical Trial Applications, Version Sponsor 1.1 (http://www.hma.eu/uploads/media/VHP_public_CBB_22_Dec_08___hk_jan12.pdf).