Data Analytics and Methods

The Agency has an ambitious plan to build up capability and capacity within EMA and across the network to deliver robust evidence for benefit-risk decision-making. In 2021, EMA made progress in a number of projects and initiatives that will strengthen scientific advice on products under development, underpin support to marketing authorisation assessments and deliver expert methods advice and data analysis for medicines on the market.
 

DARWIN EU

The aim of the Data Analysis and Real World Interrogation Network (DARWIN EU) is to deliver real-world evidence from across Europe on diseases, populations and the uses and performance of medicines. This will enable EMA and national competent authorities in the European medicines regulatory network to use these data whenever needed throughout the lifecycle of a medicinal product. 

In 2021, DARWIN EU made significant steps forward. EMA launched a tender procedure for the selection of a service provider to establish and run, under the guidance of the Agency, the Coordination Centre for the DARWIN EU network. The selection will be concluded in early 2022. 

Also, the DARWIN EU Advisory Board was formed in June 2021. It is co-chaired by EMA’s Executive Director Emer Cooke and Karl Broich from the German Federal Institute for Drugs and Medical Devices representing the HMA and includes representatives from key stakeholder groups such as patients and healthcare professionals, payer and health technology assessment (HTA) organisations, national medicines regulatory authorities, national data permit authorities, the European Commission and ECDC. The mandate of the board is:

• strategic advice and recommendations to the project team on establishing DARWIN EU and its use of the European Health Data Space (EHDS);
• coordination and alignment with relevant European and EU Member State initiatives and policies;
• supporting two-way communication on DARWIN EU with the EU Regulatory Network, stakeholders and the EHDS.

EMA will be a principal user of DARWIN EU as it will request studies to support its committees’ scientific evaluations and regulatory decision-making. EMA’s role in DARWIN EU is crucial as it is responsible for: 

• linking real-world data studies to core benefit risk decision-making;
• providing strategic direction and setting standards;
• overseeing the coordination centre and monitoring its performance;
• ensuring close links to European Commission policy initiatives, particularly the EDHS, and delivering pilots.

DARWIN EU will also contribute to developing the EHDS and close collaboration took place with the joint action to deliver European principles for the secondary use of health data, Towards the European Health Data Space (TEHDAS).  
 

Big data steering group work plan 2021-2023 and EU Big Data Stakeholder Forum

The HMA-EMA joint Big Data Steering Group adopted its multiannual workplan in June 2020 and updated it in August 2021. The workplan aims to increase the utility of big data in regulation, from data quality through study methods to assessment and decision-making. It is patient-focused and guided by advances in science and technology. The workplan includes eleven priority recommendations of the HMA-EMA Joint Big Data Task Force. 

2021 deliverables included adoption of a Network Data Standardisation Strategy and a suite of stakeholder workshops including on artificial intelligence (AI), real-world meta-data, standards and real-world evidence. In December 2021, the European medicines regulatory network organised the second annual Big Data Multi-Stakeholder Forum. The Forum informed stakeholders on the delivery of the data pillar of the Network Strategy 2025 via the HMA-EMA joint Big Data Steering Group workplan, provided an opportunity to listen to stakeholders’ views and feedback and discuss the areas for collaboration. 165 registered participants attended the Forum online and others could follow via the live stream on the web.