Real-world data helps to improve patient care, decision-making and health policy

Digitisation in healthcare has led to an increase in health data. Electronic patient records, billing data, data from administrative and regulatory agencies, and data collected by medical devices and wearables provide a wealth of information. "A great opportunity," thinks physician, epidemiologist, and researcher Rok Hrzic. "Because it is not only about more data, but also about data from target groups that were previously rarely involved in scientific research."

University lecturer and researcher Timo Clemens wholeheartedly agrees. “Real-world data (RWD) improve the foundation for research and decision-making by increasing the quantity and the kinds of data available. This allows us to answer questions we could not answer before, leading to better and sometimes timelier decision-making in diagnostics, care and policy making. Moreover, RWD require less time and effort to collect compared to data obtained from clinical studies. At the same time, we face significant technical and methodological challenges to the routine use of RWD in decision-making.” Rok explains: “RWD data have been collected for purposes other than research and decision-making. This means they are stored in a variety of formats and encodings. There may be important semantic differences between datasets, and there may be biases that we don't yet fully understand.” Timo: “In addition, there are legal issues. We know where the data are collected and stored, but that doesn't mean we can access them.”

In a study commissioned by the European Commission, colleagues from the Department of International Health, joined by other partners, assessed the use of RWD in scientific research, clinical care, regulatory decision-making, health technology assessment and health policymaking. Timo: "In this study, we mapped existing RWD initiatives and the data infrastructures, disease areas, methodologies for data pooling and analysis, and the questions they addressed. We also identified the challenges associated with using RWD. An important conclusion of the study is that the use of RWD in Europe is still in its infancy. While there are examples of best practices, they represent isolated solutions with limited synergy between them. The European Health Data Space, proposed by the European Commission in 2022, could solve most health data exchange obstacles. An ex-ante assessment of this proposal for the Euregional cross-border effects conducted with colleagues from ITEM/Faculty of Law concluded that there is support from the field to address the challenges. But there has been scepticism about how far existing tailor-made solutions for bilateral data exchange can be scaled to the context of the entire EU.”