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Accelerating Clinical Trials in the EU

Clinical trials methodologies

These objectives ensure that all relevant EU expert groups pool their expertise and align their priorities in order to accelerate the development of future guidance, in collaboration with relevant stakeholders.

Direct deliverables to fulfil these objectives will include:

  • a roadmap to clarify the guidance landscape with an overview of the existing, ongoing and planned key guidance activities;
  • methodology workshop to facilitate alignment, consolidation and accelerate guidance development;
  • internal best practice on how to develop guidance documents and ensure implementation;
  • internal process for coordination of guidance development to ensure sustainable coordination of methodology guidance development.

Related documents

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General publications8 March 2024
ACT EU multi-stakeholder workshop on methodology guidance report
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General publications11 September 2023
Complex clinical trials – questions and answers
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General publications11 September 2023
Recommendation paper on decentralised elements in clinical trials