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The CTR: Implementation by Member States – Get it Right – Now

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The EU Clinical Trials Regulation and its implementation are having a major impact for Europe’s attractiveness as a haven for conducting clinical research. If the EU and Member States get it wrong – they may lose out in the fierce competition between the different major geographical areas: North America; Asia; Latin America; and Europe. Since competition also exists within Europe between Member States and between subsidiaries of pharmaceutical companies, there are substantial expectations that multiple initiatives will present themselves for implementing best solutions to translate the new Regulation into practice.

Every country has as substantial interest in attracting clinical trials: early access for patients to innovative medicines; enhanced learning for medical teams about new therapeutics a significant boost for the recognition of scientific research teams and employment.

Companies consider an efficient organisation of the clinical trials assessment as essential for the selection of that particular Member State as the host country of the trials and even as the reporting Member State in the joint and coordinated assessment. Consequently, practically all Member States are working, often with stakeholders, including national trade associations and academics sponsors, to review their current systems and their way of working through competent national authorities and ethics committees.

By 2016, still numerous – frequently technical – questions will need to be addressed, including: how to organise the joint scientific assessment and train staff in new processes; and how to set up and provide access to the portal/ database. These are only a couple, but very important areas. Existing voluntary networks, such as the Clinical Trials Facilitation Group (CTFG) and the Voluntary Harmonisation Procedure (VHP), under the auspices of Member States’ Agencies, provide substantial learnings for decision-making on the way forward – and now with 28 Member States. The previous assessment experience of the VHP offers a fantastic platform and Member States should increase their exchanges within this framework.

The big question remains as to how far Member States will manage to re-challenge, streamline or dust off national specificities, which neither provide the patient with additional safety nor support the robustness of a clinical trial, but which can be counterproductive to European harmonization as intended. Changes need to go hand-in-hand with a change of mindset – but how is this possible? Examples include specific national registers for clinical trials and the organisation of the ethics review system.

In Nordic states there are, for example, in-depth discussions on how ethics committees might operate across the countries in a more collaborative way. Thankfully, the spirit and common objectives seem to exist but would still benefit from an even stronger political push at governmental level.

Or, as is the case in Germany, an additional authorisation in line with the self-standing national radiation protection legislation is needed, but this additional authorisation process is currently not synchronised with the authorisation process of clinical trials – which ends up creating significant delays before a study can be started. All these aspects need to be changed in light of the upcoming implementation.

In France, a pilot phase will begin in September, in cooperation with all the stakeholders, including Ethics Committees, to provide support for the required new organisation.

Things are moving quickly at European level and constructive dialogue between Member States in order to raise Europe as a key area for clinical research is THE challenge.

The message is – we need to get it right now. But the change of mindset needed, requires strong leaders in the Member States: in governments; national agencies; ethics committees; academia and industry. Otherwise opportunities may be lost for at least another decade – and perhaps irrevocably.

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Written by

VP Global Regulatory Affairs International, Eli Lilly and Company

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