RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2022 > 1 > EU launches clinical trials transformation initiative

EU launches clinical trials transformation initiative

Posted 18 January 2022 | By Joanne S. Eglovitch 

EU launches clinical trials transformation initiative

The EU has just kicked off a new initiative meant to transform how clinical trials are initiated and run to promote clinical research in the region. The initiative is meant to address “a relative absence of EU impactful multi-state trials” prompted by the COVID-19 pandemic.
 
The initiative aims 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,” said an announcement from the European Medicines Agency (EMA).
 
The goals of the initiative are spelled out in a paper entitled “Accelerating Clinical Trials in the EU (ACT EU),” that lists priority areas for promoting such research. The paper was developed by the European Commission, the Heads of Medicines Agencies (HMA) and EMA.
 
EMA said that the initiative will build on the application of the Clinical Trials Regulation and the launch of the Clinical Trials Information System (CTIS) on 31 January 2022. (RELATED: EMA readies CTIS go-live plan, Regulatory Focus, 8 October 2021)
 
The initiative will also “strengthen the European environment for clinical trials, whilst maintaining the high-level of protection of trial participants,” said EMA.
 
According to the paper, about 40% of clinical trials are sponsored by academia and 60% are run by the pharmaceutical industry. “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 initiative is also meant to address a “challenging” environment for clinical trials in the EU. “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.”
 
The ACT EU strategy paper lists ten priority actions for 2022/2023; including the following:
 
  • Mapping existing initiatives and developing a governance rationalization strategy aligning different expert groups
  • Developing key performance indicators (KPIs) and dashboards to track performance of the European clinical trials environment
  • Establishing a multi-stakeholder platform, including patients, after stakeholder analysis
  • Modernizing good clinical practice (GCP) informed by the development of International Council for Harmonization (ICH) guidance
  • Analysing clinical trial data leveraging academic, nonprofit, European and international initiatives
  • Planning and launching a targeted communication campaign engaging data protection experts, academia, subject matter experts, health technology assessment bodies and healthcare professionals
The proposal to establish ACT EU was endorsed by HMA in November and by EMA’s Management Board in December 2021, and the initiative will be co-led by the European Commission, EMA and the HMA.
 
ACT initiative paper

 

© 2022 Regulatory Affairs Professionals Society.