EMA unveils first projects as data partners join DARWIN EU project

Two years ago, the EMA proposed a set of recommendations to unlock the potential of big data for public health, headlined by the creation of a platform to access and analyse healthcare data from across the bloc.

The Data Analysis and Real World Interrogation Network (DARWIN) EU platform aims to create a network of databases of verified, quality, and secure content that can be used to support "scientific evaluations and regulatory decision making" with reliable evidence from healthcare practice.

More than two years on, the EU medicines regulator has now selected the first set of data partners to collaborate with DARWIN EU, which focuses on real-world evidence collected on a patient's health status or delivery of healthcare from a variety of sources, other than conventional clinical trials.

With the first data partners on board, the regulator can now move ahead with the start of its first studies.

One will focus on the epidemiology of rare blood cancers, to try to get a handle on how prevalent they are within Europe, while another will focus on valproate – a drug for epilepsy recently thrust into the spotlight over the risks it poses to unborn children in pregnancy.

The third study will look at the use of antibiotics in Europe to inform future work on the rapidly emerging threat of antimicrobial resistance (AMR).

"These studies mark the start of a rapid ramp-up in the number of studies conducted to support regulatory decision making," said the EMA in a statement.

"The aim is that by 2025 DARWIN EU will deliver approximately 150 real-world evidence studies per year," it added.

The first eight partners – which include both public and private institutions and are listed here - all have access to real-world healthcare data from one or more sources such as hospitals, primary care, health insurance, biobanks, or disease-specific patient registries.

The EMA says it intends to add at least 10 new partners to its roster every year, with a new call due to go out in 2023. Any prospective partners have to be able to offer continuous data collection with at least annual data updates, a lag time of less than six months in data availability for analysis and capture of health outcomes and medicines prescribing or dispensing.

Other proposals in the EMA's 2020 big data document – prepared in collaboration with the Heads of Medicines Agencies - included measures to enhance guidance and resources within the EU regulatory network for data quality and data discoverability and to build up computing and analytical capacity.