EU adopts 10-part workplan to guide the acceleration of clinical trials

Regulatory NewsRegulatory News | 30 August 2022 |  By 

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have adopted ten priorities as part of a larger workplan to  accelerate the adoption of clinical trials in the EU. The priorities are meant to steer the agencies’ work from 2022-2026.
The workplan was adopted under the auspices of the EC-HMA-EMA initiative Accelerating Clinical Trials in the EU (ACT EU), which launched earlier this year. (RELATED: EU launches clinical trials  transformation initiative, Regulatory Focus 18 January 2022)
ACT EU aims to transform how clinical trials are initiated and run and to promote clinical research in the EU.
The workplan “builds on the entry into application of the Clinical Trials Regulation (Regulation (EU) No 536/2014) and the activities already underway in the European regulatory network to support clinical trials. The workplan highlights key focus areas to further facilitate innovation in clinical trials, stakeholder engagement and regulatory network collaboration.”
It lays out deliverables that include mapping and governance, good clinical practice (GCP) modernization, enhanced clinical trial data analytics and clinical trial safety reforms.
The first priority area is to map out the clinical trials regulatory landscape with expert groups working in different areas, including the Clinical Trials Coordination and Advisory Group (CTAG), the Clinical Trials Coordination Group (CTCG), and the Good Clinical Practice Inspectors Working Group (GCP IWG). The aim of the mapping exercise is to develop a governance strategy to coordinate the work done by different clinical trial experts and working parties.
The plan also relies on the implementation of the Clinical Trials Information System (CTIS) to ensure the “successful implementation” of the Clinical Trials Regulation (CTR). This calls for launching monthly key performance indicators (KPIs) tracking the number of sponsors signing up for CTIS. EMA has been publishing these KPIs since January, and the latest report was published on 23 August. (RELATED: EMA reports steady rise in clinical trial applications registered in CTIS portal, Regulatory Focus 23 August 2023)
The regulators also call for the development of a multi-stakeholder platform in 2023 involving patients, healthcare professionals and academics to evaluate the clinical trials environment.
“There is a need for a unifying platform involving all stakeholders to support a more holistic discussion across the clinical research landscape. Such dialogue 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,” the workplan states.
Additionally, the workplan addresses the need for GCP modernization to align with the International Council for Harmonisation’s E6(R2) guideline. The plan calls for convening a multi-stakeholder event geared at delivering a “responsive guideline which accounts for stakeholders’ perspectives and advances in technology and clinical trial design.”
The plan also stresses the value of clinical trials data analytics collected by the European medicines regulatory network (EMRN), though it concedes that “these data … are currently difficult to access, process and interpret due to the existence of multiple data sources.” It adds that a publicly accessible EU clinical trials dashboard will be built, with development penned for Q1 2023.
To support the plan, the regulators said they will launch a targeting communication strategy involving various stakeholders, such as data protection experts, academia, small and medium-sized enterprises (SMEs) and Health Technology Assessment (HTA) bodies to “remind sponsors of training to support the application of the CTR and the mandatory use of the Clinical Trials Information System (CTIS).
Other aspects of the workplan include consolidating the process for managing scientific advice, facilitating the development and publication of guidance on complex trial designs, training safety assessors and developing training to support the development of high-quality medicines.
EMA workplan


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