Clinical trials in the EU could be about to move much faster under new proposals by the European Medicines Agency (EMA).
In its Accelerating Clinical Trials in the EU (ACT EU) initiative, the EMA has set out 10 actions for 2022 and 2023 that will transform how the essential studies are initiated, designed, and run.
The EMA anticipates that the changes will transform the region into a focal point for human studies and life sciences and attract potential new business.
This is being proposed through the modernization of good clinical practices, the implementation of guidelines on a range of topics, and the development of a central dashboard to track the performance of the EU clinical trial environment.
The EMA is also seeking to further integrate ethics committees into the clinical trial and medicines regulatory life cycle, support large-scale multinational clinical trials, and reduce administrative burden.
The ten priorities identified by the EMA are:
Map existing initiatives and develop a governance rationalization strategy (aligning different expert groups and working parties in the EMRN and ethics infrastructure).
The successful and timely implementation of the CTR and its implementing acts.
Establish a multi-stakeholder platform, including patients, after stakeholder analysis.
Implement the GCP modernization informed by the development of guidance at ICH.
Analyze clinical trial data leveraging academic, non-profit, European, and international initiatives, improving the impact of policymaking and funding on research outputs to support evidence-based decision-making.
Plan and launch a targeted communication campaign to engage all enablers (including data protection experts, academia, SMEs, funders, HTA bodies, healthcare professionals).
Reinforce the coordination between scientific advice on CT approval and CT design and link to the methodologies working party domain.
Develop and publish key methodologies guidance, e.g., on AI/ML impacted CTs, complex trials, decentralized CTs, and IVDR/CTR interface.
Successfully establish CT safety monitoring and bridge to the EU4Health Joint Action and start its integration into a pre- and post-marketing safety monitoring framework.
Deliver a clinical trials training curriculum including modules on drug development and regulatory science with links to universities and SMEs (serving as an educational ‘ecosystem’).
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