Large amounts of data are generated daily through devices, electronic health records, social media, clinical trials and spontaneous adverse reaction reports. Insights derived from this data will increasingly be used by regulators to assess the benefit-risk of medicines across their lifecycles. To benefit and make careful use of the data collected, regulators need a deeper understanding of the data landscape.

On 15 December 2020, the first big data Stakeholder Forum was hosted by EMA on behalf of the HMA-EMA joint Big Data Steering Group, aiming to give stakeholders the opportunity to provide feedback regarding the HMA-EMA big data priority recommendations and perspectives on their implementation.

EAACI represented the healthcare professionals’ point of view and supports the outcomes of the Forum in regards to the use of big data within the field.

Real World Data can fill the gaps and complement evidence lacking from clinical trials, but needs the adoption of common standards across nations to overcome variations in collection, analysis and even IT systems at hand. Clear guidelines to ensure data quality, accessibility representativeness and interoperability of data, along with secure and ethical aspects are called for.

Health digitalization is impossible without investing in digital and health education. Considering the varying infrastructure, knowledge, and other capabilities of research centres and hospitals across Europe, it is vital that big data initiatives do not exacerbate existing inequality.  

Researchers welcomed the availability of large amounts of quality data, and the collaborative development of "solid epidemiologic methods". In order to enhance trust in the regulatory system three pillars should be promoted: transparency, independence, and standards, in line with the priorities developed by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance(ENCePP).

The development of standards should build on previous initiatives based on academic-industry partnerships, conducting research not only together with, but also independently from, any market interests. Both industry and clinicians mention the language used to discuss these topics, and how important it is that everybody is "speaking the same language".

Ioana Agache, EAACI Past President