Proposals for Changes to the Clinical Trials Directive
Nearly four years on from the implementation of the European Clinical Trials Directive (2001/20/EC), a conference was held to discuss whether the stated aims of the objective are being achieved. The conference, organised by the EMEA and held at its offices in London, provided a forum at which representatives of interested parties could present their experiences with the existing legislation and discuss whether the issues arising could be resolved within the existing regulatory framework or whether a revision of the current legislation was necessary.
Although it was the aim of the Directive to
- protect the rights, safety and well being of trial participants,
- simplify and harmonise the administrative provisions governing clinical trials and
- establish a transparent procedure that will harmonise trial conduct in the EU and ensure the credibility of results,
the fact that the Directive had to be implemented through national legislation in each individual member state means that the second two objectives remain far from being achieved.
One of the key issues raised by the Industry was the administrative burden arising from these differences in implementation of the Directive and interpretation of the guidelines across the member states: this becomes more acute when a company is conducting a multinational clinical study, as is increasingly the case. They suggested that the guidelines could be revised to clarify definitions and streamline assessment procedures, while the legislation could be amended to provide a single point of entry or even centralised assessment or some form of mutual recognition for clinical trial authorisations (CTAs). They also requested new legislation that would be able to capture, prospectively, the complexity of developing new clinical trials in the field of advanced therapies.
Non-commercial sponsors expressed concern at the complexity of the different pieces of relevant legislation and also felt that clinical trials should be categorised according to the risk associated with the protocol and not the study's commercial or non-commercial objective. They wanted clear guidance on the respective roles of the competent authorities and the ethic committees. Through these recommendations (among others) they aimed for more and better clinical research in the EU.
Representatives from ethics committees (EC) emphasised that there should be no centralisation of the ethics opinion at EU level. A clear separation of duties between competent authorities and ECs and better communication between all parties was desirable. They wanted greater access for ECs to information on clinical trials via the EudraCT and Eudravigilance systems. The management, training, self-evaluation and membership of ECs was also an issue for these contributors.
Representatives of the National Competent Authorities (NCA) pointed out that, since 2004, considerable harmonisation has already been achieved and that cohesion, simplification and transparency were the keys for the success of European research. These issues, they suggested, could be resolved through existing channels and a change to the Directive was not required at this time. They oppose a centralised system and want to maintain national competences. A number of elements of the NCA procedures could be improved by increased collaboration, harmonisation and data sharing between authorities, for example in the areas of data requirements and assessments, roles of NCAs and ECs, SUSAR reporting and assessment and electronic submissions. Better information exchange with sponsors, support for non-commercial sponsors and guidance though a dedicated website were also recommended. These and other measures would, they believed, increase the number of clinical trials conducted in the EU.
The most important overall consideration for the patient groups was the key objective of maintaining the EU as a global reference for excellence in science and ethics in clinical trials, both within and outside the EU. They also highlighted, among many recommendations, a need for greater patient involvement in ethics committees, guidelines on informed consent forms in terms of both content and structure and free-of-charge treatment for patients at the end of a trial.
The representative of the European Commission Directorate-General for Research addressed activities in support of clinical research in the EU and highlighted the need for coordination with DG Enterprise, Industry and the EMEA on the legislative/regulatory issues, with non-commercial sponsors for key issues such as the definition of 'non-commercial clinical trial' and 'sponsorship' and with ECs, regulators, CAs and research organisations.
Thus, a series of proposals emanated from the conference which the European Commission could consider as a starting point for immediate and long term improvements. Some proposals, such as better harmonisation of interpretation and implementation or clarification of the roles of the NCAs and ECs, seemed to be common themes across the spectrum of stakeholders. Some of these changes could be introduced within the current legal framework, but others would require amendment to the existing legislation. Akos will be monitoring the activities of the Commissionin this area over the coming months and years so that we can contribute to the consultation procedures for new guidelines and legislation and also advise our clients of any proposed or imminent changes that might impact on their regulatory strategies or development programmes.
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