EMA Highlights Trial Innovation, Real-World Data Advances in New Report
The European Medicines Agency (EMA) reported “remarkable” progress, despite the pandemic, in a mid-point assessment of its “Regulatory Science Strategy to 2025” to build a more adaptive regulatory system that will encourage innovation — including advances in clinical trials and a new real-world data (RWD) network.
The 65-page report, which looks at progress made from March 2020 to December 2022, notes the launch of the EU’s Clinical Trial Information System, which went live as a searchable public website in January 2022. The agency also launched the Accelerating Clinical Trials initiative to help develop the EU as a center for innovative clinical research.
Other advances included building the Data Analysis and Real-World Interrogation Network, publishing a catalog of observational data sources to be used in medicine regulation, publishing an executive summary about the best approach to generate and collect patient experience data, and holding a stakeholders’ workshop to support developers.
Although stakeholders initially shared concerns that the pandemic might limit resources for the strategy, the EMA said it expects progress to continue in the next two years.
Read the EMA report here: https://bit.ly/40rLpjw.