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ACT EU multi-annual workplan 2022-2026 gepubliceerd
Op 2 september 2022 is het Accelerating Clinical Trials in the EU (ACT EU) multi-annual workplan 2022-2026 gepubliceerd.
The workplan lays out deliverables and timelines. In 2023, they include:
- Large, multinational clinical trials: establishing a support process specifically aimed at academic sponsors in order to make the EU a more attractive region to conduct clinical research
- Implementation of the CTR: a particular focus on Clinical Trial Information System (CTIS) and CTR training activities and trouble-shooting any issues encountered by clinical trial sponsors
- Multi-stakeholder platform: will be established in 2023 to facilitate the evolution of the clinical trials environment through regular dialogue between all stakeholders, including patients, healthcare professionals and academia, to find practical solutions to enable and drive change
- Modernisation of good clinical practice: ACT EU will support not only the adoption but also the implementation of revised EU guidelines in technology and clinical trial design
- Facilitation of innovative clinical trial methods: the initiative will issue guidance on decentralised clinical trials by the end of 2022 and publish a methodology roadmap to identify and prioritise key advances in clinical trial methods.
bron: EMA news 'ACT EU multi-annual workplan 2022-2026' d.d. 30 augustus 2022.
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Het 'EU Decentralised Clinical Trials (EU DCT) project'
"Since March 2022, the Clinical Trials Coordination Group (CTCG) is responsible for the project management of the EU Decentralised Clinical Trials (EU DCT) project. The EU DCT project is part of the priority actions conducted in the context of the Accelerating Clinical Trials in the EU (ACT EU), which started at the same time as the launch of the Clinical Trials Information System (CTIS) and the implementation of the Clinical Trials Regulation (EU) No 536/2014 (CTR). The DCT project represents a broad collaboration across the European Medicines Regulatory Network with a cross-disciplinary project group including amongst others clinical trial authorisation experts, ethical experts and Good Clinical Practice (GCP) inspectors across Member States. It aims to provide a harmonised and transparent approach for the use of DCT elements in clinical trials. To this end, a Recommendation paper on the use of DCT elements in clinical trials is planned to be published by the end of 2022."
bron: HMA, Clinical Trials Coordination Group
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