Currently, the European clinical trials environment is quite challenging. The COVID-19 pandemic has shown a relative absence of EU impactful, multi-state trials. In addition, the disharmony of Regulatory requirements between the Member States has complicated the submission of multi-state trial applications. To address these scenarios, the EC, the Heads of Medicines Agencies (HMA), and the EMA proposed a new initiative entitled, “Accelerating Clinical Trials in the EU (ACT EU).”
This initiative aims to strengthen the European environment for clinical trials and promote the development of high-quality, safe, and effective medicines. In addition, the initiative has priority actions for the year 2022-23. Let’s get to know them.
ACT EU Initiative Objectives
- Optimize the EU environment for clinical research while maintaining high-level protection of trial participants, data robustness, and transparency.
- Develop the EU as a focal point for clinical research and better integrate clinical research in the European health system.
- Strengthen the leadership and coordination on clinical trial authorization and execution.
- Optimize ethical oversight and further integrate ethics committees into the clinical trial and medicines Regulatory lifecycle.
- Support marketing authorization and access throughout the medicine lifecycle.
- Strengthen clinical trials that deliver decisional evidence for unmet medical needs, rare diseases, and vaccines and therapeutics for public health crises and pandemics.
ACT EU Priority Actions
The following key priorities have been identified to establish ACT EU and its objectives:
- Map existing initiatives and develop a governance rationalization strategy.
- Track the performance of the European clinical trials environment by developing KPIs and a dashboard.
- Establish a multi-stakeholder platform, including patients, after stakeholder analysis.
- Implement Good Clinical Practices (GCP) modernization informed by the development of guidance at International Council for Harmonization (ICH).
- Analyze clinical trial data leveraging academic, non-profit, European, and international initiatives.
- Plan and launch a targeted communication campaign to engage all enablers like data protection experts, academia, SMEs, and healthcare professionals.
- Develop and publish key methodologies guidance.
- Deliver a clinical trials training curriculum including modules on drug development and Regulatory science with links to universities and SMEs.
Finally, this initiative strives to accelerate clinical trials in the EU, further develop them for clinical research, and promote high-quality, safe, and effective medicines. Manufacturers willing to gain access to the European market must be aware of these clinical trials initiatives. Are you willing to submit your Clinical Trial Application (CTA) as per the country-specific regulations? Do you need end-to-end support to file your application? Consult a Regulatory expert like Freyr. Stay informed. Stay compliant.