01/18/2022
Photo by Ricardo Gomez Angel on Unsplash
The European Medicines Agency (EMA), European Commission (EC), and the Heads of Medicines Agencies (HMA) published “Accelerating Clinical Trials in the EU” (ACT EU) in January 2022, a strategy paper outlining their collaborative initiative to transform clinical trials in the European Union (EU). The purpose of the initiative is to work together with the EU Clinical Trials Regulation (Regulation (EU) No 536/2014) (CTR) to support strengthening how European clinical trials are designed, initiated, and conducted, while maintaining participant safety, robust and quality data, and transparency.
The CTR goes into application January 31, 2022, repealing the EU Clinical Trials Directive (2001/20/EC). On the same date, the Clinical Trials Information System (CTIS) goes live. The CTIS is the EU portal and database applicable for clinical trials under the CTR.
The strategy paper lists ten priority actions for the next two years:
“1. Map existing initiatives and develop a governance rationalisation strategy (aligning different expert groups and working parties in the EMRN and ethics infrastructure).
2. The successful and timely implementation of the CTR and its implementing acts.
Develop KPIs and dashboard to track performance of the European clinical trials environment.
Including the promotion of larger, multinational trials specifically in the academic setting.
3. Establish a multi-stakeholder platform, including patients, after stakeholder analysis.
4. Implementing the GCP modernisation informed by the development of guidance at ICH.
5. Analyse 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.
6. Plan and launch a targeted communication campaign to engage all enablers (including data protection experts, academia, SMEs, funders, HTA bodies, healthcare professionals).
7. Reinforce the coordination between scientific advice on CT approval and CT design and link to the methodologies working party domain.
8. Develop and publish key methodologies guidance e.g. on AI/ML impacted CTs, complex trials, decentralised CTs and IVDR/CTR interface (to strengthen links between innovation and scientific advice fora).
9. 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.
10. 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’).”
The initiative aims to achieve the optimal environment for clinical trials within the EU by:
Strengthening leadership and coordination for authorization
Further integrating ethics committees into the clinical trial lifecycle
Supporting a broader scope of multinational clinical trial centers
Reducing burden and increasing efficiency
Engaging stakeholders to develop and market patient-oriented treatments
Encouraging treatments for rare diseases and therapeutics or vaccines to improve public health
The strategy paper, the CTR, and the CTIS together is a step in achieving the goal for clinical trials innovation that was part of the European medicines agencies network strategy to 2025. It follows the trend of modernization of GCP by consulting stakeholders and patients with the condition being studied to inform study design and high quality outcomes.
- The Clinical Pathways Team
Enjoy this blog? Please like, comment, and share with your contacts.