This report is a summary of an IMI-hosted event called IMI Impact on data, part of a series of events intended to showcase the successes of projects launched since the programme’s inception in 2008. Held online in June 2021, the Impact on data event brought together people involved in IMI-funded research on real-world data, whether as researchers in projects from academia, project partners from the pharmaceutical sector, or others involved in the strategic direction of IMI.
For decades, people have been talking about how difficult it is to use health data in research. The IMI Impact on data event zoned in on three practical examples of how this problem can be solved to produce meaningful results.
Terttu Haring, Global Head for Clinical Digital Innovation Sanofi, introduced the session by reminding everyone of the enormous amounts of data collected in healthcare and clinical research settings. “Very often, at least in the past, it has been quite unstructured, and siloed between different research groups,” she said, with academics and pharma companies with their own data. She lauded the launch of the IMI programme in 2008 and its intention to “significantly improve the efficiency and effectiveness of the drug development process by making everyone come to the same table to work together.”
She spoke of the IMI digital health projects, whose focus is on unlocking potential and opportunities for the entire field of healthcare, across all indications, potential medicines and patient groups. They have produced tangible outputs, she said, and she is proud that there are so many pharma companies and academics participating, adding that “with all the commitment, we have an obligation to use what comes out” of IMI research projects. She outlines the three areas that have been defined as the focus for the future: big data, real world data, and making it available to be exploited.
“Be aware that we are moving forward with many new initiatives along these lines: wearables, data capture, biomarkers based on digital tech. We are change agents, carriers of the knowledge and new ways of working.”
Dr Mats Sundgren, Director Health Informatics AstraZeneca, lauded the EHR4CR project, which ended in 2016 but whose outputs continue to allow for the maximum exploitation of electronic health data to help design and recruit for clinical trials. The project, he said, laid the foundation for a completely new technology. “We didn’t really understand it,” in the beginning of the project, he said of the potential, but it is clear that what emerged is now a central reality and will become increasingly important for the future. He described the problems with clinical trial design, especially in estimating the number of patients that could be recruited, traditionally through manually surveying hospitals. This is where the EHR4CR technology fits in: it allows for sophisticated research queries to study the feasibility of a clinical trial “with the scale of data that we need” and described the new professional platform, InSite, that emerged from the project. The platform has grown from the 11 hospitals involved in the project to over 1,200 today.
“This dynamic way of using data is the only way forward,” he said, comparing it to the static way in which things have been done in the past, which tends to overly complicate things. “It really provides value for Astra Zeneca and the many pharma companies using it, he said, adding that the technology has very interesting opportunity to perform pragmatic clinical trials and offers a good example of Nash equilibrium.
Jennifer Lane, Versus Arthritis Clinical Research Fellow in Trauma and Orthopaedic Surgery University of Oxford, leads the EHDEN project. Dr Lane told the audience that the past year highlighted the importance of initiatives like EHDEN, which she described as a trusted ecosystem for better healthcare decisions. She explained the EHDEN mission: to generate a EU-wide federated network of real-world data sources standardised to a common data model (called OMOP) and to mine it to generate large-scale reliable evidence, combined with “a community of collaborators who love open science.”
“Think of the network like an electronic travel adaptor for data”, where each data source keeps its own form and identity but the adapter allows it to participate within the network to generate results at scale. Dr Lane talked about how EHDEN has been able to help in different studies, including a five-day study-a-thon on outcomes of different types of knee replacement surgery, and a fully-virtual unplanned event to study COVID-19 therapeutics such as Hydroxychloroquine, that took the place of a planned face-to-face meeting that had to be cancelled due to the pandemic.
The COVID therapeutics study allowed them “to address the noise in the data caused by the pandemic, on a global scale” and included over 350 researchers, in 15 different Microsoft Teams channels, took place over 88 hours, and looked at over 10k publications and hundreds of patient cohorts. Together, they demonstrated and published some risks associated with the use of Hydroxychloroquine. The response to the publication was unprecedented, she said, and garnered much media attention, and also fed into advice from regulators.
“One of the most satisfying things about being a part of this was seeing the impact that the work had on the emergency authorisation of drugs,” she said, “and the change in regulatory body opinion,” which was made possible by the transparency of their research which allowed anyone to appraise the data, and check the study design and results. “At a time when there was great uncertainty, it was great to be part of a community that was trying to address this based on a solid foundation of years of work and expertise.”
“We were able to mount a rapid response. It was a great example of the power of EHDEN and the way we look at observational science in a changing world."
Prof. Lars Bullinger, Director of the Department of Haematology, Oncology and Tumourimmunology, at the Charité Universitätsmedizin in Berlin, is involved in the IMI HARMONY project. He described the project’s huge mission: to bring together all of the different stakeholders involved in treating blood cancers, to set up a massive platform of harmonised data and outcome measures and to mine this big data to speed up the development of new drugs to treat these cancers. So far they have put together over the largest dataset of its kind in Europe with over 70,000 patients and 10,000 more expected.
He explained a pilot study researching genomic aberrations and gene-gene interactions that should allow the identification of which patients will likely benefit from a stem cell transplantation and patients that can safely postpone transplantation. It will also produce new targets for pharmaceutical research that should lead to innovative new medicines.
The problems that plague the use of data in research, and what is IMI doing about it