The European Medicines Agency (EMA) wants to speed up your clinical trials. Through the Accelerating Clinical Trials in the EU (ACT EU) initiative, the EMA and other bodies have set out (PDF) 10 actions they plan to prioritize in 2022 and 2023 to transform how studies are initiated, designed and run.
With the Clinical Trials Regulation taking effect at the end of the month, and the European Commission calling for change in its Pharmaceutical Strategy, the EMA and other EU bodies have kicked off a project that is intended to turn the region into a focal point for human studies and better integrate research into the health system. The EMA and its collaborators are aware of the shortcomings of the current system.
“The current environment for clinical trials is challenging,” the EU bodies wrote in their ACT EU proposal. “Disharmony of regulatory requirements between Member States complicate the submission of multi-state trial applications. The resulting slower trial authorisations could negatively affect research responsiveness, which is particularly worrisome during a rapidly evolving public health crisis.”
Working with the commission and the heads of national regulators, the EMA plans to address the issues by focusing on 10 priority activities. The priorities include the modernization of good clinical practices, the creation of guidelines on topics such as artificial intelligence and decentralized clinical trials and the development of a dashboard to track the performance of the EU clinical trial environment.
The EMA published the priorities alongside a list of six objectives for the initiative. The top objective is to optimize the environment for clinical research in the EU while “maintaining high-level participant protection, data robustness and transparency.”
Specifically, the EMA wants to further integrate ethics committees into the clinical trial and medicines regulatory life cycle, support large-scale multinational clinical trials and reduce administrative burden.