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On 30 August, the European Commission (EC), Heads of Pharmaceutical Institutions (HMA) and the European Medicines Agency (EMA) released the EU Accelerated Clinical Trials Study (ACT-EU) work plan
The work plan builds on the recommendations of the European Drug Regulatory Network (EMRN) Strategy 2025 and the European Commission's European Medicines Strategy, with emphasis on further promoting clinical trial innovation, stakeholder engagement and regulatory focus areas
At the same time, the work plan sets out deliverables and timelines, including:
Clinical trials for large multinationals: Establish a support process specifically for academic sponsors to make the EU a more attractive clinical research region
Clinical trials for large multinational corporations:
Implementation of CTR: Special attention is paid to clinical trial information systems (CTIS) and EU Clinical Trial Regulation (CTR) training activities and addressing any issues encountered by clinical trial sponsors
Implementation of CTR:
Multi-stakeholder platform: To be established in 2023, it will facilitate the evolution of the clinical trial environment through regular dialogues between all stakeholders, including patients, medical professionals, and academia, to find practical solutions
Multi-stakeholder platform:
Modern good clinical practice: The clinical research program will support not only the adoption of revised EU guidelines in terms of technology and clinical trial design, but also their implementation
Modern good clinical practice:
Decentralized Clinical Trials: The plan will release decentralized clinical trials by the end of 2022 and publish a method roadmap to identify and prioritize key advances in clinical trial approaches
Decentralized Clinical Trials: