Launched last week, the Accelerating Clinical Trials in the EU (ACT EU) initiative sets out to ‘transform how clinical trials are initiated, designed and run’. It is run by the European Commission, the Heads of Medicines Agencies and the European Medicines Agency.
The initiative spots numerous opportunities to develop clinical trials in Europe: including modernizing how clinical trials are run; promoting larger, multi-national trials across the bloc; and creating an educational ‘ecosystem’ in drug development and regulatory science with universities and small and medium enterprises.
Lessons from COVID
The initiative acknowledges that 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," notes the strategy paper.
"Disharmony of regulatory requirements between Member States complicate the submission of multi-state trial applications. The resulting slower trial authorizations 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 centralized marketing authorization 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.”
However, it also notes that Europe has many of the ingredients needed to create a favorable environment for innovation and research: including a thriving life sciences sector; an extensive healthcare infrastructure able to support clinical research, and an abundance of healthcare data from public health systems.
“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," says the strategy.
"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 ACT EU strategy paper lists ten priority actions for 2022/2023, including enabling innovative trial methods, establishing a multi-stakeholder platform, and supporting the modernization of good clinical practice.
