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Time to reopen discussion on a more collaborative ethics committee assessment – perhaps cross-border?

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The new EU Clinical Trials Regulation (EU-CTR), likely to enter into force in 2016, aims to address some of the issues associated with the existing Clinical Trials Directive. The EU-CTR will continue to ensure applications to run clinical trials are assessed to high scientific, technical and ethical standards, as under the Directive. However, it is hoped that the Regulation will lead to assessments being made with increased efficiency and harmonisation, with a reduced administrative burden, and within stated timelines. This will ultimately contribute to bringing innovative medicines to patients in a timelier manner.

As predictable assessment timelines are crucial to ensure that Europe remains a competitive location for clinical research, it is important that the timelines set out by the legislation are respected by both the sponsor and Member States (MS).

A more coordinated, harmonised EU cross-border assessment process has already been outlined by the new legislation, including the concept of a single decision per MS. Without specifying how it will be achieved, the approach outlined in the EU-CTR will require regulators and ethics committees to work together to conduct the assessment and reach a single decision.

For many years, regulators across the EU have collaborated under the VHP (voluntary harmonisation procedure) to assess applications for clinical trials; the successes and lessons from this voluntary procedure can be used to further develop a coordinated procedure under the EU-CTR. As ethics committees also play a crucial role in the assessment of medicines, non-legislative initiatives to promote greater cooperation and collaboration between ethics committees would lead to a convergence of EU assessment standards, improve the pace of approval and help ethics committees keep within stated timelines. Recent initiatives provide guidance on the way that collaborations could be achieved:

  • The Nordic Trial Alliance (NTA) is a 3 year pilot project (2013-2015) aimed at increasing the attractiveness of Nordic countries for clinical research. This includes promoting the collaboration of Nordic countries in areas such as the monitoring of clinical research and stimulating increased communication between Nordic ethics committees. The progress of the NTA should be monitored as it could provide a good model of how collaboration can be successful.
  • Similarly, a UK-driven proposal in 2012 discussed the idea of optional accreditation and mutual recognition of ethics committees within the EU. The proposal put forward the possibility of a pilot scheme involving 2 or 3 MS ethics committees who would recognise each other’s assessment processes as equivalent to their own. The sharing of best practices between MS ethics committees would allow equivalence to be confirmed. It was suggested that, if successful, other MS could then join the scheme, leading to a convergence in EU assessment standards. However, the proposal was put on hold awaiting the release of the finalised EU-CTR.
  • Also of note are EUREC NET (a network of European ethics committees) and the EFGCP (European Forum for Good Clinical Practice), who have both aimed to improve information exchange and mutual learning between ethics committees. Additionally, some MS are beginning to explore how to involve ethics committees under the VHP.

Given that the EU-CTR introduces a more harmonised, EU cross-border approach to scientific assessment, perhaps it is time to reopen discussions on whether a more collaborative approach to assessment could be used by ethics committees too.

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Written by

VP Global Regulatory Affairs International, Eli Lilly and Company

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