EU Lays Out Work Plan for Improving Clinical Research in the Trade Bloc
The European Medicines Agency, the European Commission and the Heads of Medicines Agencies have published a list of priorities for their ACT EU program, which launched at the beginning of the year with a goal of enhancing the EU’s clinical trial capabilities.
The multi-year work plan for the Accelerating Clinical Trials in the EU (ACT EU) initiative lays out ten priority actions, as well as deliverables and proposed timing for each, that are meant to spur growth in clinical trial innovation, stakeholder engagement and regulatory collaborations within the trade bloc as it seeks to become more competitive as a destination for clinical research.
“The aim is to further develop the EU as a focal point for clinical research, promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system,” the EMA said. “ACT EU will strengthen the European environment for clinical trials, whilst maintaining the high level of protection of trial participants, data robustness and transparency that EU citizens expect.”
For example, under the first priority action, “mapping and governance,” the EU will map out existing initiatives within its regulatory network in order to develop a strategy that coordinates the work done by different clinical trial expert groups across its complex regulatory landscape. This process is anticipated to be carried out in Q4 2022.
The work plan also includes the task of modernizing GCP, specifically by implementing ICH E6(R3). To this end, the EU plans to hold a multi-stakeholder workshop in the first quarter of 2023, followed by making changes in EU guidances in the third quarter and developing a communications and change management strategy in the fourth.
In addition, the EU intends to ramp up its efforts on clinical trial training by creating an “educational ecosystem” with help from universities and subject matter experts. This will ultimately deliver a comprehensive set of training modules on drug development and regulatory science and is set to begin in Q4 2022. These efforts are expected to take one year, approximately, according to the work plan.
The trade bloc also plans to address the rising use of complex trial designs, such as basket trials and master protocols, and will publish guidance on decentralized trials (DCT) by year’s end.
Read the full work plan here: https://bit.ly/3KV98C3.