Evidence & Strategy

Real‑world data (RWD) refers to health data collected through routine clinical care rather than controlled clinical trials. In Nordic countries, RWD is primarily sourced from national health registers, electronic health records, quality registers, prescription databases, and biobanks. These data are population‑based, longitudinal, and can be reliably linked across healthcare settings using unique personal identification numbers, making Nordic RWD particularly well suited for regulatory and health technology assessment (HTA) purposes.

Real‑world evidence (RWE) is the robust clinical and economic evidence generated by analyzing RWD using validated epidemiological and statistical methods. In regulatory and HTA settings, Nordic RWE is used to address evidence gaps that remain after clinical trials, such as long‑term effectiveness, safety in broader patient populations, treatment patterns, and healthcare resource utilization. It can also support post‑authorization safety studies, supplementary regulatory submissions, and joint clinical assessments.

In summary, Nordic RWD is the underlying data infrastructure, while Nordic RWE is the decision‑ready evidence derived from it. The strength of the Nordic model lies in its ability to produce high‑quality, generalizable evidence that is increasingly recognized by regulatory authorities and HTA bodies internationally. Accordingly, Nordic RWE is a critical complement to randomized clinical trials, helping to inform regulatory decisions, reimbursement evaluations, and value assessments throughout the product lifecycle.

RWE can support all the phases of a product’s lifecycle.

While randomized controlled trials (RCTs) are the foundation of drug development, designed to evaluate efficacy under controlled conditions, real‑world evidence (RWE) provides a complementary perspective across the product lifecycle. By leveraging real-world data, it enables assessment of how treatments are used and perform in routine clinical practice, including broader and more diverse patient populations. In the Nordics, this is typically achieved using national health registers and linked healthcare data, which support longitudinal follow-up and capture patient pathways across different care settings.

During drug development, RWE has been used to inform trial design, identify relevant patient subgroups, and understand disease burden or treatment pathways ahead of pivotal studies. When RCT data are limited, for example in rare diseases or small populations, RWE can also be used to support external or historical control arms and other innovative study designs.

After regulatory approval, the focus shifts. RWE is used to understand how the treatment performs in routine clinical practice, outside the controlled trial setting. This includes evaluating real‑world effectiveness, long‑term safety, treatment patterns, and use in broader and more representative patient populations. Post‑approval RWE also plays a key role in fulfilling regulatory commitments and informing reimbursement and health technology assessment decisions, where stakeholders often want evidence beyond what can be generated in pre‑approval trials. 

For regulatory authorities such as the European Medicines Agency and the U.S. Food and Drug Administration, real-world evidence (RWE) is commonly used to support post‑approval activities. This includes post‑authorization safety studies and efficacy studies, monitoring long‑term effectiveness and safety, evaluating use in broader or under‑represented patient populations, and fulfilling regulatory commitments after launch. In specific circumstances, such as rare diseases, small populations, or label extensions, RWE can also contribute to assessments where traditional trials are not feasible or where additional RWE is needed. 

Health technology assessment (HTA) bodies such as National Institute for Health and Care Excellence in the UK and Canadian Agency for Drugs and Technologies in Health in Canada use RWE in a slightly different way. They rely on RWE to assess how a treatment performs in routine clinical practice and to inform value‑based decisions. This often includes evaluation of real‑world comparators, treatment pathways, healthcare resource use, and longer‑term outcomes. RWE helps HTA bodies evaluate whether the benefits observed in trials translate into real‑world impact and whether a therapy justifies reimbursement at the proposed price.

Across both regulatory and HTA settings, RWE plays a key role in reducing uncertainty, supporting reassessments over time, and informing decisions as additional real-world data (RWD) become available. High‑quality data sources, such as Nordic health registers with full population coverage and long follow‑up, are particularly well suited to these purposes and are increasingly used in both regulatory evaluations and HTA submissions internationally.

With the introduction of the EU HTA Joint Clinical Assessment (JCA), the role of RWE is becoming even more important. JCAs aim to provide a shared clinical assessment at the EU level, while national bodies retain responsibility for pricing and reimbursement decisions. In this context, RWE is increasingly used alongside trial data to reduce uncertainty, supplement evidence on comparators and patient populations, and inform national interpretation and adaptation of JCA conclusions, particularly after launch, when additional RWD become available.