The Big Data Steering Group set up by European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has published its third workplan that sets key actions to be delivered in the period 2022-2025.

Big data are extremely large, rapidly accumulating datasets captured across multiple settings and devices, including wearable devices and electronic health records. Big data can complement the evidence from clinical trials by filling knowledge gaps on a medicine and can help to better characterise diseases, treatments and the performance of medicines, accelerating medicine development, improving treatment outcomes and facilitating earlier patient access to new treatments, particularly in the field of rare diseases and paediatrics, where disease-based registries can be one of the best ways to assess long-term treatment outcomes, as well as adverse events.

Fondazione Gianni Benzi is actively involved in this sector by leading many research activities based on Data Science tools and skills, implemented within patients’ registries (Multiregional Thalassaemia Registry) and drug registries (EuOrphan), surveys and other research data collections. A lot of efforts are also made to guide and provide FAIRification expertise for data sharing and health data reuse through these registries and other data sources.

In this framework, the new EMA-HMA workplan will allow to further enhance the efficient integration of data analysis into the evaluation of medicinal products by regulators. It lays out deliverables and timelines including for the following areas:

  • The Data Analysis and Real World Interrogation Network (DARWIN EU), EMA’s network of data and services in Europe for a better use of real-world evidence when assessing medicines
  • A data quality framework for the European Union regulatory network to be delivered by the end of 2022, following the analysis and exchanges on data quality with a wide range of stakeholders including patients, healthcare professionals, regulators, pharmaceutical industry and academia
  • A good practice guide on real-world metadata and a public catalogue of European real-world data. In addition, searching for information from regulatory documents will be enhanced through the development of analytics tools and standardised clinical trial protocols
  • The delivery of training on Biostatistics, Pharmacoepidemiology and Data Science for regulators with targeted access for patients, healthcare professionals and academics

Discover more on the EMA website!

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