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EFGCP Workshop on

Options and Challenges for Ethical Assessment in the Clinical Trial Regulation Proposal

7 & 8 November 2012 - Husa President Hotel, Brussels, Belgium

Organised by EFGCP on behalf of the Roadmap Initiative for Clinical Research in Europe

In July 2012, the European Commission adopted a proposal for a Regulation on Clinical Trials to resolve a number of problems identified with the current legislation. In the legislative process this proposal is now subject to discussions by the European Parliament and the Council representing the 27 Member States and in parallel by all stakeholders affected by it.

One of the key changes proposed concerns the assessment and decision system for clinical trial applications. In the proposal the Commission defines the regulatory environment and the objectives to be achieved. Fulfilling these requirements will need a critical review of the options for national clinical trial approval systems in the Member States and the types of collaboration between competent authorities and research ethics committees. The workshop is meant to provide a platform for a constructive discussion on the ways research ethics committees could be involved and ensure an appropriate ethical assessment of the clinical trials in future.

What is the background for the new legislation?

The current legislation has been criticised by nearly all stakeholders involved into clinical trials. This led to several hearings, workshops and two consultation rounds launched by the European Commission, to identify the extent of the problem and the reasons for the decrease of number of clinical trials in Europe.

In these discussions and exchanges unnecessary bureaucracy, duplication of submission dossier review procedures by competent authorities and ethics committees, especially for multi-national clinical trials and the current complex authorisation and supervision processes had been highlighted as a reason for Europe to loose attractiveness for research and development:

According to the Commissioní s impact assessment since the implementation of the clinical trials directive in 2004, the number of clinical trials activated in Europe has dropped by 25% in a research environment which has increasingly be subject to global competition. This decreasing number is equally worrying different communities which are engaged in or benefit from clinical trials: academia, clinicians, patients and pharmaceutical industry and the European society as a whole.

The absence of an efficient regulatory framework is one significant reason for this. Demanding regulatory requirements have increased the costs of clinical trials. This applies in particular for international clinical trials, which by their nature are much more impacted by administrative burden of the current framework resulting in prolonged trial activation timelines and unjustified complexity of their set-up.

What did stakeholders call for?

What is needed is a balanced and efficient approach that allows fast access for patients but also meets highest safety and quality standards for the protection of trials subjects. During the consultations and discussions broad consensus had been achieved between academic and commercial sponsors on the need for an EU harmonised and streamlined clinical trial authorisation system, involving a single submission procedure primarily for multi-national clinical trials. This had been communicated through the Road Map Initiative for Clinical Research in Europe in 2010.

What did the Commission propose?

The proposed regulation sets clear objectives and timelines for the assessment of and decision on clinical trials by Member States while respecting international guidelines such as set by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and World Medical Associationís Declaration of Helsinki. Since Member States have the exclusive competence to organise responsibilities at a national level and the EU has no right to legislate in this area, the proposal clearly isolates items relevant to the national competent authorities and ethics committees. Therefore, it will be up to each Member State to legislate the organisation of national authorities and ethics committees while respecting regional and cultural aspects.

The proposed concept for submission, assessment and decision process for a clinical trial application includes the single submission for all Member States through an EU electronic portal including a clear and harmonized list of documents to be submitted. The subsequent assessment procedure proposed would enable trial sponsors to obtain approvals from all participating member states within 40-70 days (depending on the nature of the trial). These timeline are reasonably competitive within the global context of R&D.

The aim of this workshop is to start a dialogue on practical implications of the Commissionís proposal for ethics committees on the following assumptions:

Each Member State will issue the authorization to run a clinical trial on the basis of a coordinated assessment integrating the scientific-technical review by competent authorities as well as the result of the national ethical assessment.

The mechanism of such an integration may require different solutions from one country to another.

Sponsors will be able to start clinical trials immediately after notification of the decision on the clinical trial by a particular Member State

The workshop provides an opportunity to reflect upon, exchange opinion and develop creative solutions on how to integrate all the aspects into one decision per Member State within the proposed timelines without compromising the established scientific/ethical review standards and the level of patient protection in all countries involved in the trial.


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