By Ludwig Burger
(Reuters) – The European Medicines Agency has set up a new centre to collect and mine more public health data from EU member states to improve the review of new drugs and provide them more quickly to patients.
So-called Real World Evidence (RWE) from hospitals and physicians’ practices have been used before for regulatory reviews of drug candidates, but advances in data processing technology offer a far greater potential.
In a statement on Wednesday, the EMA said it had set up the Coordination Centre for the Data Analysis and Real World Interrogation Network, or DARWIN EU, to provide RWE requested by EMA itself and member states’ regulators.
Likely starting later this year, the centre would also answer requests by national bodies that determine the benefits and reimbursement prices of new drugs, Peter Arlett, Head of Data Analytics and Methods Task Force at EMA, told Reuters.
The real-world data will include how common the targeted disease is, the size of patient populations, as well as safety and effectiveness of medicines and vaccines, the statement added.
“By 2025 we anticipate DARWIN having the capacity to conduct over 100 observational studies, so real world evidence, per year. That’s really a transformational increase capacity for the European Union,” said EMA’s Arlett.
The RWE would supplement data from controlled trials in a research setting.
Examples of the EU regulator’s past use of RWE include the 2018 approval of complex cell therapies against blood cancer, Kymriah by Novartis and Yescarta by Gilead, where the comparison of how patients would have fared without the treatment were RWE-based.
More recently, EMA scrambled to process public-health data on the normal rate of occurrence of extremely rare conditions that were linked to COVID-19 vaccines, including clotting disorders or heart inflammation, to determine the role vaccination played.
“The availability of timely and reliable real-world evidence can lead to innovative medicines becoming more quickly available to patients,” EMA said in its statement, adding the data would also inform the use of medicines already on the market.
(Reporting by Ludwig Burger; Editing by Toby Chopra, William Maclean)
