A new collaboration aims to bridge the gap between regulatory approval and the real-world information that clinicians and health authorities need to make informed treatment decisions.
Apr 7, 2026
Sofia Linden
Ledidi and NordicRWE, both members of Oslo Cancer Cluster, have entered a strategic partnership to conduct hybrid real-world evidence studies and pragmatic clinical trials across the Nordic region, according to a recent press release.
The evidence generated through these studies is intended to inform the decisions that directly affect patient access to treatment, such as health technology assessments, reimbursement submissions and clinical guideline development.
“Hybrid real-world evidence and pragmatic clinical trials unlock a new level of evidence by combining deep clinical phenotyping with population-scale Nordic registry data. This partnership enables faster, more relevant and decision-ready evidence for launch HTA and lifecycle management – supported by NordicRWE’s expertise in real-world evidence and Ledidi’s secure and scalable infrastructure,” commented Christian Jonasson, Research Director in NordicRWE.
Clinical decisions – by physicians, health authorities and payers – depend on evidence that reflect how treatments perform in real-world patient populations. The Nordic health registries are among the most comprehensive in the world, but they typically lack granular clinical information.
This limits their usefulness for questions that matter most to patients and clinicians, such as which subgroups respond to a given therapy, how treatment outcomes compare in routine practice, and more.
“The Nordic registries represent an extraordinary research asset, but realising their full potential for sponsors requires structured prospective data that captures what registries cannot. Together with NordicRWE, we can offer a seamless pathway from study design through data capture to registry-linked outcomes – all within a single, secure infrastructure,” commented Einar Martin Aandahl, CEO of Ledidi.
The collaboration includes two complementary approaches.The first involves hybrid observational studies. These are studies that combine multiple research methods within a single study to enhance validity, efficiency and real-world evidence.
In this case, the studies will collect data on symptoms, biomarkers, quality of life and other clinical details at point of care and link this with longitudinal data from national registries in Norway, Sweden, Denmark and Finland.
This will produce datasets with both clinical depth and population-level follow-up, enabling research into treatment effectiveness, and patient heterogeneity that neither source can deliver alone, according to the press release.
The second approach of the partnership involves pragmatic randomized controlled trials (pRCTs). These are research studies designed to evaluate the effectiveness of interventions in real-world clinical settings. They compare interventions against standard care to inform decisions for patients, providers and policymakers.
These trials will regain the rigour of randomisation, while recruiting from real-world patient populations across the Nordic healthcare system and track outcomes through existing registry infrastructure. This will make them faster, less costly and more generalisable than convential RCTs, according to the press release.
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