Today, the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have launched an initiative to transform how clinical trials are initiated, designed and run, referred to as Accelerating Clinical Trials in the EU (ACT EU). The aim is to further develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system.
Purpose
This paper sets out proposals for the initial set up of an EU clinical trials transformation initiative: Accelerating Clinical Trials in the EU (ACT EU). The paper includes high-level regulatory network objectives, governance, organisation, priority actions for 2022-2023, and resourcing. The implementation of ACT EU will contribute to delivering the Network strategy to 2025 and the Commission Pharmaceutical Strategy.
Background
Europe has many of the ingredients needed to create a favourable environment for innovation and for research and development including a world class life sciences sector, an extensive healthcare infrastructure able to support clinical research, an abundance of healthcare data available from public health systems, and a high level of academic medicine. About 40% of clinical trials are sponsored by academia, often small and nearly all mono-national and about 60% by pharmaceutical industry, with a recent shift to more academic trials being done during the COVID19 pandemic. Both groups of trials need greater support and enablement for Europe to flourish as a global focus for clinical research, both in the development of new medicines and in the refinement of use of existing medicines.
The current environment for clinical trials is challenging. Recent events including the COVID-19 pandemic has demonstrated a relative absence of EU impactful multi-state trials and analysis of clinical trial applications continues to show registration of a preponderance of small single member state studies. 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. In addition, the expenses to conduct trials are high. Taken together these might in part explain the results of an analysis of centralised marketing authorisation applications having shown a fall in the inclusion of trial results generated in the EU. To address this, the lessons learned from regulatory flexibilities set up during the pandemic could be applied for a more responsive research environment.
Recognising the need for improvements, combined with the application of the Clinical Trials Regulation on 31 January 2022, the EMRN strategy to 2025 and Commission Pharmaceutical Strategy have put forward recommendations to foster innovation in clinical trials.
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