ACT EU Recommendations for DCTs

What is ACT EU?

The Accelerating Clinical Trials in the EU (ACT EU) initiative, launched in January 2022, aims to develop the EU further as a competitive centre for innovative clinical research. It aims to deliver on the clinical trial innovation recommendations of the European medicines agencies network strategy and the European Commission’s Pharmaceutical strategy for Europe. The initiative builds on the Clinical Trials Regulation (CTR) and Clinical Trials Information System’s (CTIS) launched on 31 January 2022. CTIS use is now mandatory in Europe for clinical trial (CT) applications, has been used for the RADIAL study which is now approved and is expected to start recruitment in Q2 2023.

The ACT EU workplan

The ACT EU 2022-2026 workplan sets out deliverables and timelines for the programme for 2022-2026. The deliverables for 2023 include the following:

• Establishing a process to support academic sponsors in enabling large multinational clinical trials.
• Supporting clinical trial sponsors to make best use of available CTIS and CTR training activities.
• Setting up a multi-stakeholder platform to facilitate dialogue between clinical trial stakeholders, including patients, healthcare professionals and academia.
• Modernising good clinical practice by supporting the adoption and implementation of revised EU  in clinical trial design.
• Facilitating innovation in clinical trial methods by publishing a methodology roadmap and further developing guidance on decentralised clinical trials.

The success of CTs relies on a multitude of stakeholders and therefore regular dialogue between all parties involved can help identifying key advances in CT methods, technology and science or roadblocks, and by finding practical solutions to enable and drive change. ACT EU has outlined a set of 10 priority actions with a key action (PA 3 as mentioned on the slide below) being the establishment of a multi-stakeholder platform (MSP).

The ACT EU Multi-Stakeholder Platform

The ACT EU MSP is expected to be the main forum where stakeholders will discuss all aspects related to clinical trials and develop a better understanding of each other’s perspectives. The platform is intended to meet regularly and discuss topics according to an established workplan. It is foreseen that the MSP will be supported by ad-hoc topic groups responsible for more technical discussions. The “ACT EU multi-stakeholder platform concept paper” outlines the key objectives and governance aspects of the MSP. It is anticipated that the ACT EU MSP kick-off meeting will take place at the beginning of Q2 2023. Recently, to initiate the setting up of the platform and its workplan, a public stakeholder consultation was launched by the EU Commission with a survey to be completed by March 3^rd at the very latest. This will be the opportunity to get feedback and interest in being part of the ACT EU MSP and on the topics that could be considered high priority for discussion in 2023-2024.

The ACT EU Multi-Stakeholder Meeting on Decentralised Clinical Trials

The T@H consortium was a key contributor at the ACT EU multi-stakeholder meeting on decentralised clinical trials (DCT)organised at EMA on October 4, 2022 on behalf of the EU DCT project. This was the opportunity to bring together participants from all areas of the research community to share perspectives on this type of clinical trials. As a result, and as announced by the vice-chair of the EU Clinical Trial Coordination Group (CTCG) at the EFPIA Multistakeholder Workshop on Enhancing Patient-Centric Outcome Measures and Clinical Trials with Digital Health Technologies held in December 2022, the CTCG released their long awaited Recommendation Paper (RP) on Decentralised Elements in Clinical Trials as a Christmas gift. The paper is one of the first deliverables of ACT EU and includes an ‘Overview of National Provisions’ which provides useful references to EU Member States’ specific requirements (e.g., for the delivery of Investigational Medicinal Products (IMPs) from sponsor/site, the shipment of IMPs from sponsor/site across boarders within the EU, or e-consent process…) to make future DCT planning more efficient. The RP should be seen though as a working document knowing it will be modified and updated with experience gained. As said at the meeting, regulators are ready to continue the dialogue with the stakeholders to facilitate the use of decentralised elements in clinical trials in the EU/EEA, while ensuring the necessary level of trial participant’s safety, and protection of their rights and dignity.