RWE 201 – Denmark – A Hub for RWE Research

Denmark has been at the forefront of real-world data (RWD) and real-world evidence (RWE) initiatives in the realm of healthcare. Danish national registries and databases, which have been maintained for several decades, provide a rich source of RWD. These databases have been instrumental in the production of RWE on various aspects of health, from drug safety and effectiveness to epidemiology and public health.

[1] The Danish National Patient Registry (NPR): This registry contains information on all hospital contacts (inpatients and outpatients) in Denmark since 1977. It is a crucial source for RWD on hospitalizations, medical diagnoses, and procedures.

>> Link: https://sundhedsdatastyrelsen.dk/da/registre-og-services/om-de-nationale-sundhedsregistre/sygdomme-laegemidler-og-behandlinger/landspatientregisteret

[2] The Danish Civil Registration System (CRS): Established in 1968, this is a central registry containing personal data for all residents in Denmark. Every individual is assigned a unique personal identifier, enabling researchers to link data across various national registries.

>> Link1: https://ugeskriftet.dk/dmj/danish-civil-registration-system

>> Link2: https://cpr.dk/

[3] The Danish Prescription Registry: This registry captures all prescriptions dispensed at pharmacies in Denmark. It provides RWD on drug utilization and is often used in pharmacoepidemiological research.

>> Link: https://sundhedsdatastyrelsen.dk/da/registre-og-services/om-de-nationale-sundhedsregistre/sygdomme-laegemidler-og-behandlinger/laegemiddelstatistikregisteret

[4] The Danish Health Act: This Act contains provisions related to the collection and use of health data. The Act supports the secondary use of healthcare data for purposes such as quality assurance, administration, and research.

>> Link: https://www.retsinformation.dk/eli/lta/2023/1011#id72c3d38b-17c0-4440-9d58-ad1098f34043

[5] National initiatives for promoting RWE: The Danish government, alongside various stakeholders, has taken steps to promote the use of RWD and RWE in healthcare decision-making. This involves fostering collaborations between researchers, healthcare providers, and the industry.

>> Link: https://www.ema.europa.eu/en/documents/presentation/presentation-real-world-data-rwd-quality-experience-danish-national-health-registers-s-knudstrup-k_en.pdf

One key advantage of the Danish system is the ability to cross-link these databases using the unique personal identifier, which enables comprehensive patient-centric research, spanning across different healthcare sectors and even incorporating social and demographic data.

These initiatives, alongside others, make Denmark a hub for RWE research, especially in the fields of epidemiology and pharmacoepidemiology.

The Danish system boasts a unique advantage in its ability to interconnect databases using a personal identifier, fostering holistic patient-centric research that integrates data from various healthcare sectors, as well as social and demographic information. This makes Denmark a leading centre for RWE research, notably in epidemiology and pharmacoepidemiology. Furthermore, the Danish Health Data Authority is pioneering AI-driven initiatives to enhance data quality in the National Patient Register (NPR), with efforts underway to detect missing cancer patient data and daily data discrepancies. Although in its early stages, the vision is to expand the use of AI and machine learning for automated data quality checks across multiple registries.

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