Executive Summary
A new UK network, led by an expert who has also worked on high-level EU data projects, has been established to test whether a common data model could help to facilitate real-world evidence studies by increasing the “usability” of data.
Source: Shutterstock
Health Data Research UK, the country’s national institute for health data science, has commissioned a coordination center that will pilot a network for delivering real-world evidence (RWE) studies using a common data model.
During the project, which has secured funding for 12 months (June 2024-June 2025), several studies will be conducted to test whether the network is ready to conduct public health, regulatory or health technology assessment (HTA) research projects.
“The main idea here was to create a pilot test for a network of data partners in the UK that will be working together to generate RWE,” Daniel Prieto-Alhambra, the RWE coordination center lead, told the Pink Sheet.
Prieto-Alhambra, who is an epidemiologist and academic clinician scientist from the University of Oxford and has also worked on DARWIN EU, said that the data could be used for regulatory purposes but also “other things, like health technology assessment (HTA) or public health research.”
“The idea is to create the network and to test it, see what is going well, what needs to be developed, and then identify needs for future development as well.”
The pilot will bring together data from up to seven hospital and primary care partners across the UK, and the data will be mapped onto the OMOP (Observational Medical Outcomes Partnership) common data model.
On 11 July, HDR UK put out a call for data partners to apply to the pilot network, with a deadline of 30 August. The network is looking for partners from across the UK that can participate in studies coordinated by the network in return for grant awards and payments.
The importance of using standardized structures for data has been demonstrated through use cases including medical product safety surveillance, comparative effectiveness research, personalized risk prediction and drug effectiveness, according to a document from HDR UK for prospective applicants to the pilot scheme
OMOP Can ‘Increase Data Usability’
The OMOP model is also used elsewhere in the world, including the EU. For example, the flagship European Health Data and Evidence Network (EHDEN) project, launched in 2018, had more than 850 million anonymized health records harmonized to the OMOP as of January. (Also see “EU RWE Projects Show The ‘Data Revolution In Health Research’ Is Here” – Pink Sheet, 21 Jun, 2024.).
Paola Quattroni, who is head of strategy and engagement for the UK HDR Alliance, told the Pink Sheet that the new pilot was a “core activity” of the alliance, which is an independent network of health care and research organizations managed by HDR UK.
“One of our strategic objectives is to encourage implementation of data standards and common data models such as the OMOP common data model, to increase usability of data,” she explained.
“The work of the RWE network coordination center will help us demonstrate the potential of OMOP as an enabler of efficient cross-nation research studies.”
“There is some good data out there, and some of that has already been standardized to OMOP. What we want to do is to bring together a network of data custodians who already mapped data to OMOP, and to facilitate use of data gathered from multiple sources, demonstrating the impact of standardized data with some clear use cases,” Quattroni said.
“If the pilot works, it will demonstrate that there is a need to have the data that is of a good quality and standardized, as well as an infrastructure that supports all that.”
The acceptance of RWE for regulatory and HTA purposes has increased in recent years. Last year, a representative of England’s HTA body NICE said it accepted RWE as a primary source of data in 20% of its appraisals. (Also see “RWE Accepted As ‘Primary Evidence’ In 20% Of NICE Appraisals Over Past Year” – Pink Sheet, 15 Nov, 2023.).
Similarities & Differences With EU DARWIN
In addition to his academic experience, Prieto-Alhambra is deputy director for the European Medicines Agency’s Data Analysis and Real World Interrogation Network (DARWIN) coordination center.
DARWIN was launched in 2022 and generates RWE for use by the EMA and national competent authorities. Although it is an EU project, two of the network’s data partners are part of the University of Oxford. (Also see “EU’s DARWIN Project To Expand Geographical Reach With 10 New Data Partners” – Pink Sheet, 12 Mar, 2024.).
Prieto-Alhambra explained that the “main similarities” between DARWIN and the UK RWE network pilot were the focus on real world data and the use of formal and related federated analytics.
“So the idea is that you map the data to a common model, in this case OMOP, and then run analytics in a federated or distributed way where we share code and get anonymized results back without really accessing patient-level data ever.”
The center does not really have a regulatory focus, and while it could be used for regulatory reasons, “it is not a regulatory center,” he explained. “DARWIN was a direct response to the EMA and is funded directly by the EMA for regulatory research.”