The Accelerating Clinical Trials in the European Union (ACT EU) initiative has been launched by the European Commission, European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) in January 2022. The vision is to transform the EU into a region that supports clinical trial development and enable collaboration and innovation at all stages of the clinical research lifecycle. ACT EU aims to transform how clinical trials are initiated, designed and run to further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system. Over the years the EMRN (European Medicines Regulatory Network) has collected a wealth of data about clinical trials through their clinical trials registers. These data are used to support regulatory decision-making, but their potential uses extend far beyond that scope.
On 25 and 26 January, EMA organised a Clinical Trials Analytics Workshop, under the ACT-EU initiative, in Amsterdam (the Netherlands). The focus of the two day workshop was on Data Analytics in Clinical Trials, looking at how data can be better used to improve public health. During this event, stakeholders had the opportunity to present and discuss how they are using or planning to use these data. Participants shared their use cases with clinical trials data. An use case for the data might be, for example, a description of how an individual or organisation intends to use the data to accomplish a specific objective, the expected outcomes and benefits of using the data in that way.
The use cases will be gathered into an EU research agenda on clinical trials analytics under which specific research projects may be funded. Participants also identified evidence gaps in the EU environment that might be addressed by access to data, data analysis and funding. These discussions will help guide EU decision-makers on improving access and usability of clinical trials data. AE Project Officer Cindy Birck attended the workshop.
https://www.ema.europa.eu/en/events/act-eu-clinical-trials-analytics-workshop-january-2024