EU Promises ‘Unifying’ Stakeholder Forum To Discuss Changes To Clinical Trial Landscape
Executive Summary
The new workplan for the EU's initiative on accelerating clinical trials lays out the timelines for a set of “priority actions,” such as mapping the European clinical trial environment and establishing a consolidated process for more efficiently managing scientific advice on trials.
EU regulators are planning to set up a “unifying” platform in 2023 where stakeholders can hold regular discussions on ways of improving the European clinical trial landscape by identifying advances in trial methods, technology and science and finding “practical solutions” to drive change in this area. A concept paper on the platform is to be issued during the third quarter of this year.
Plans are also on the table to map existing clinical trial activities starting in Q4 2022, to identify and address any problems with the implementation of the EU Clinical Trials Regulation (CTR) and the Clinical Trials Information System (CTIS), and to adapt good clinical practice (GCP) to take account of new trial designs and data sources.
In addition, a scheme to support the conduct of large multinational trials, particularly those involving academic sponsors, is expected to be launched in the first quarter of 2023.
The initiatives and timelines are described in the 2022-2026 workplan that accompanies the Accelerating Clinical Trials in the EU (ACT EU) initiative, which was launched in January this year and is intended to transform the way that trials are initiated, designed and conducted. (Also see "New EU Clinical Trials Transformation Initiative Gets Underway" - Pink Sheet, 17 Jan, 2022.)
ACT EU, a collaborative venture of the European Commission, the European Medicines Agency and the EU Heads of Medicines Agencies, focuses on 10 priority actions intended to consolidate and make the most of the new clinical trial landscape introduced by the CTR and CTIS.
The 2022-2026 workplan, published on 30 August, gives more detail of the priority actions as well as timelines for guidance, workshops and other supporting activities planned over the next few years. It takes account of recommendations by the European medicines agencies network strategy to 2025 and the European Commission’s Pharmaceutical Strategy, which involves a wholesale overhaul of the pharmaceutical legislation.
The workplan notes that the European clinical trial landscape is complex, with various expert groups working on different areas such as guidance, scientific advice and clinical trial approvals.
As a first step towards addressing this complexity, mapping of existing clinical trial activities will begin in Q4 2022, with the first phase focusing on a number of trial governance bodies: the Clinical Trials Coordination and Advisory Group, the Clinical Trials Coordination Group, the Commission Expert Group on Clinical Trials and the Good Clinical Practice Inspectors Working Group.
Activities will also be undertaken to ensure the successful implementation of the CTR, such as tracking the performance of the European clinical trial environment and addressing any implementation problems. These will be identified via a survey to be conducted in the third quarter of this year, and in the fourth quarter, a process to prioritize and resolve these issues will be launched.
Multi-Stakeholder Platform
According to the workplan, clinical trial stakeholders exist at both EU and member state level and there is “little opportunity for regular dialog” among them.
The planned multi-stakeholder platform will allow participants to conduct a more “holistic” discussion across the clinical trials landscape. This will “facilitate the evolution of the clinical trials environment by helping to identify key advances in clinical trial methods, technology and science, and by finding practical solutions to enable and drive change,” it says.
A concept paper explaining how stakeholders can contribute to the design of the platform will be issued in the third quarter of this year, and the platform itself is expected to be launched during the second quarter of 2023, followed by stakeholder events in Q3 of that year.
GCP & Analytics
As for modernizing GCP in Europe, the workplan says that the priority action will support the implementation of the International Council for Harmonisation’s revised ICH E6(R3) guideline which is intended to apply GCP to “the increasingly diverse range of clinical trial types and data sources.” It is also expected to offer flexibility in terms of allowing the use of technological innovations in trials. A stakeholder workshop is to be held in Q1 2023, with changes being implemented in EU guidance documents in Q3 2023.
Action will also be taken on trial data analytics, the workplan says, noting that over the years a “wealth of data” about clinical trials has been collected, but this is “currently difficult to access, process and interpret” because of the existence of multiple data sources.
A publicly accessible EU clinical trial dashboard will therefore be developed with researchers, policymakers and trial funders to support evidence-based decision making. Work on the dashboard will begin in the first quarter of 2023, with a workshop to be held in the second quarter to identify topics of common interest.
To disseminate information about these actions to relevant stakeholders, a targeted communication campaign will be undertaken starting in the third quarter of this year to “engage all enablers of clinical trials,” including data protection experts, academia, small and medium-sized enterprises (SMEs), funders, health technology assessment bodies and health care professionals.
The campaign will “remind sponsors of training to support the application of the CTR and the mandatory use of CTIS,” in line with the transition period for the latter, which ends on 31 January 2023, the workplan says. The commission has just said that it has no plans to extend the transition period deadline for the mandatory use of CTIS, despite industry concern that some member states are not yet fully prepared for evaluating part II of trial dossiers submitted via CTIS. (Also see "EU Rejects Calls To Extend Clinical Trial Regulation Transition Period" - Pink Sheet, 19 Jul, 2022.)
This action will include setting up a dedicated website for ACT EU in the second quarter of 2023, which in Q1 2024 will be linked to the multi-stakeholder platform.
Scientific Advice, Novel Trial Design
The scientific advice environment can be “complex to navigate” for sponsors, particularly academic institutions or small and medium-sized enterprises. The EMA therefore plans to set up a consolidated process from the first quarter of 2023 that it says should efficiently manage scientific advice and improve coordination across relevant stakeholders.
Noting that novel trial designs and methodologies bring both opportunities and challenges, the workplan says there is a need to develop and publish key methodologies guidance as well as “strengthening links between innovation and scientific advice.”
Guidance on complex clinical trials has already been published. (Also see "EU Offers Advice On Running Complex Clinical Trials Under CTR" - Pink Sheet, 10 Jun, 2022.) As a follow-up, a workshop on the subject, as well as one on decentralized trials, will be held in the fourth quarter of 2022. (Also see "Plans Press On To Harmonize Decentralized Clinical Trial Requirements In EU" - Pink Sheet, 8 Aug, 2022.)
Clinical Trial Safety
Also included in the workplan is a plan for the member states to work together on improving trial safety by means of a “coordinated work-sharing assessment”. This work is connected with the activities of the "EU4Health Joint Action Safety Assessment Cooperation And Facilitated Conduct Of Clinical Trials" (an initiative also known as SAFE CT).
The overall goals of this joint action are “improving the quality of safety data in clinical trials and marketing authorization, reinforcing member state surveillance expertise and capacity, and harmonizing and facilitating clinical trials in the EU/European Economic Area," the workplan says.