Introduction to DAC
The Data Analysis Center (DAC) at the Danish Medicines Agency (DKMA) leverages big data, including real-world data (RWD) from Danish health registries, DKMA’s internal data on adverse drug reactions and clinical trial raw data. This data is used by DAC to provide real-world evidence on the use, safety and performance of medicines and medical devices to enhance the capacity of DKMA to derive actionable insights that benefit patients and the broader healthcare system. This initiative may be summarised as:
“Big data, better drugs”
This aligns with the new vision of the Network Data Steering Group: “Trusted medicines by unlocking the value of data”. With Director of Department Claus Møldrup at the helm of DAC, DKMA is committed to positioning their national and international data initiatives within a strategic framework that aligns with its mission to ensure safe and efficient medicines and safe medical devices.
DAC is actively driving this agenda as a data partner in DARWIN EU® (Data Analysis and Real World Interrogation Network) under the European Health Data Space (EHDS), further strengthening Denmark’s position as a leader in European health data research and innovation.
"As data analysis becomes increasingly critical in the pharmaceutical sector, it enables us to assess the effectiveness and safety of both newly approved and existing medications. Through robust, data-driven insights, we can identify emerging drug utilisation patterns, inform the development of novel therapies, and contribute to the evolution of treatment strategies, both in Denmark and across Europe," says Claus Møldrup.
"Denmark possesses some of the most comprehensive and high-quality health data in the world. This offers a unique opportunity to advance both research and the development of healthcare solutions. However, it also demands a strategic and ethical approach to data usage to maximise value for patients and the healthcare system," he adds.
This vision underscores DAC's essential role in shaping the future of healthcare by leveraging data to drive continuous improvements in patient outcomes and system efficiency, all while adhering to regulatory and scientific standards.
Competencies
- Pharmacoepidemiology: Expertise in pharmacoepidemiological methods is crucial for interpreting data and exploring associations between drug or device exposure and health outcomes. It involves the application of robust study designs, such as cohort, case-control and cross-sectional studies, that can provide evidence to support causal inferences when appropriately analysed.
- Statistical analysis: Proficiency in advanced statistical methods is essential for analysing large datasets, particularly when evaluating the effectiveness and safety of pharmaceuticals and medical devices. This includes expertise survival analysis, regression models, propensity score matching and Bayesian methods to control for confounders.
- Machine learning and AI: Knowledge of machine learning algorithms (e.g. decision trees, random forests, neural networks) and their application to large datasets is increasingly important for identifying hidden patterns, predicting outcomes and assessing long-term safety and effectiveness.
- Data integration: Ability to integrate various data types (e.g. clinical trials, electronic health records, insurance claims, patient registries) and ensure data harmonisation, which is essential for generating meaningful insights from diverse datasets.
- Data visualization: Skills in visualising complex data using tools, software, and programming environemnts such as R, Python (with libraries like Matplotlib, Seaborn), Tableau or Power BI. Clear visualisations help stakeholders understand key insights, trends and patterns in patient outcomes.
- Data governance: Understanding of data governance principles, including data quality, privacy and security standards (e.g. General Data Protection Regulation) is essential when handling personal data on individual health to ensure compliance with legal and ethical requirements.
- Pharmacovigilance: Comprehensive understanding of pharmacovigilance principles, including monitoring medicine safety is essential when analysing RWD for drug safety. This includes expertise in identifying, assessing and mitigating adverse drug reactions.
- Ethical data use: A solid understanding of ethical considerations surrounding the use of health data, particularly in relation to patient privacy and informed consent. This includes applying ethical frameworks to balance the potential for scientific advancement with the need for data protection.
- Cross-disciplinary collaboration: Ability to work effectively with multidisciplinary teams, including clinicians, regulatory experts, biostatisticians, and IT professionals, to ensure that data analysis aligns with clinical and regulatory objectives.
- Stakeholder communication: Ability to clearly and effectively communicate complex data findings to both technical and non-technical stakeholders, including researchers, policymakers, healthcare providers and regulatory bodies. This includes translating data insights into actionable recommendations for improving patient safety and treatment effectiveness.
- Reporting and documentation: Strong skills in documenting methodologies, results and conclusions in a transparent and reproducible manner, which is essential for regulatory submissions, peer-reviewed publications, and internal reports.
- Project management: Proven project management skills to lead large-scale data analysis projects. This includes planning, resource allocation and timeline management as well as ensuring alignment of analysis aligns with strategic goals.
- Leadership and strategy: Ability to lead cross-functional teams, particularly in addressing new challenges within regulatory activities. This includes strategy development for data analysis, timeline adherence and guidance on scientific, ethical and regulatory considerations.
- Regulatory pharmaceutical science: Expertise in pharmaceutical regulation compliance, including drug development and evaluation, as well as clinical trial oversight. Risk assessment, pharmacovigilance, data analysis, quality assurance and regulatory strategy to ensure the safety, efficacy and quality of medicines.
Denmark possesses some of the most comprehensive and high-quality health data in the world. This offers a unique opportunity to advance both research and the development of healthcare solutions
National Initiatives
One of the central tasks of DAC is to support DKMA’s internal departments as a whole by providing data analysis.
DAC actively supports DKMA’s core objectives through targeted initiatives, such as conducting detailed price analysis for the Pharmacoeconomics & Availability department, performing drug risk assessments in collaboration with the Pharmacovigilance department to ensure drug safety. These assesments can involve signal validation to detect potential risks or emerging trends associated with medicines. These efforts strengthen DKMA’s capacity to provide precise data-driven insights that can support regulatory decision-making.
PHAIR
The aim of PHAIR is to set the basis for a national drug surveillance system that will increase the quality of life of patients in Denmark. PHAIR represents a novel approach to pharmacovigilance, which could make Denmark Europe's frontrunner in real-time detection, analysis and prevention of side effects in pharmacotherapy.
The aim is to build, collect and communicate a secure, privacy preserving nationwide network, which will combine primary and secondary healthcare data with epidemiological and AI methods, and automation. A key novel element is the involvement and integration of patient’s knowledge from design to development and review processes. This state-of-the art system will enable an unbiased side effect surveillance in real time that is far less vulnerable to labour and time-intensive handling.
With the Covid-19 vaccine as the test case, a treatment with unprecedented rapid roll-out and socioeconomic impact, the aim is to apply the above system and complement ongoing vaccine safety surveillance activities by facilitating real-time analysis of side effects and potential discovery of hitherto unknown side effects.
Read more on www.phair.dk
Other national initiatives
DKMA is taking part in both the methodological groundwork, analyses, communication activities and introduction of such type of new technology in regulatory use together with the Pharmacovigilance department.
International initiatives: EU projects
REDDIE
Randomised controlled trials are fundamental to evidence-based medicine. With the digitisation of RWD from sources such as devices, wearables and electronic health records stored in large national registries, new opportunities have emerged to evaluate the effectiveness and safety of innovative technologies, including medicines, medical devices, diagnostics and digital health solutions. This approach is being implemented through the REDDIE project.
REDDIE (Real-World Evidence for Decisions in Diabetes) focuses on leveraging RWD to advance the understanding and integration of these technologies. Such data are particularly valuable for managing long-term conditions like diabetes mellitus, where medications, lifestyle interventions and digital technologies often work in synergy.
Read more on www.reddie-diabetes.eu/
We are currently contributing to the development of an R package designed to help build and analyse Bayesian networks. This package, called bnstruct, includes tools for learning the structure of these networks using different search methods. Additionally, the package supports features like creating bootstrap samples, handling missing data through imputation and performing inference, which makes it a powerful tool for working with complex datasets.
Real4Reg
Advancing methods and technologies drive innovation in healthcare. Research on data tools for regulatory decision-making and health technology assessment (HTA) is essential for improving medicines and monitoring drug safety and effectiveness. Real4Reg focuses on optimising RWD analysis, addressing safety, effectiveness, interoperability, accessibility and sustainability. These efforts are crucial for ensuring acceptability and translating innovations into impactful health policies, systems and clinical practice. The project aims to integrate findings into training on best practices and enhance guidelines for regulatory and HTA bodies across Europe, which will ultimately support better decisions about medicines and improve patient health.
Four main tasks of Real4Reg project:
- To assess the value of RWD from national healthcare registers and claims data for population-based insights on amyotrophic lateral sclerosis and breast cancer (diagnosis, treatment, outcomes).
- To demonstrate how RWD tackles ethical or practical questions beyond clinical trials, aiding regulatory evaluation, HTA and improving external validity and statistical precision.
- To develop a good practice example for post-authorisation safety analyses of RWD, improve observational risk estimation methods and evaluate the impact of regulatory warnings on broad-spectrum antibiotic use.
- To prepare a good practice example for assessing drug effectiveness and repurposing using RWD during the post-authorisation stage.
Read more on www.real4reg.eu/about/consortium-partners/
DKMA/DAC led two first use cases from 1 January 2023 to 31 August 2024. DAC facilitated access to data from the Danish Health Data Authority for the project and contributed to data analyses across all use cases. For the period 1 September 2024 to 31 December 2026, Aarhus University has assumed leadership of these two use cases in which DAC will continue to support Real4Reg in close collaboration the university.
IDERHA
Significant improvements in the health and well-being of citizens, in healthcare services and in scientific insights could be achieved if the persistent obstacles to leveraging heterogeneous health data resources are overcome. Integrating and analysing health data across sectors and along the continuum of care can contribute to improved healthcare; however, this ambition is not yet realised. The IDERHA project addresses the obstacles that limit appropriate access to, sharing of, use and reuse of digital healthcare and patient data. This will enable regulatory and HTA decision making for integrated health research, making it possible to better meet the needs of patients and healthcare professionals while enhancing innovation within the EU healthcare system.
Read more on www.iderha.org/
DKMA/DAC is contributing to WP6 (work package 6) by actively participating in meetings and assisting in the drafting of the Global Regulatory Best Practices Analysis report. Additionally, they support the development of recommendations for appropriate criteria to facilitate regulatory and HTA acceptance of evidence generated from heterogeneous healthcare data. In addition, DAC is a member of the Integrated Data Access Governance Council, which sets priorities and oversees the quality and timeliness of the work package deliverables.
IMPROVE
Healthcare professionals, pharmacists, researchers and health regulators throughout the EU generate and use large volumes of essential patient-related healthcare data that are critical to the quality and effectiveness of their work. Unfortunately, complex obstacles still make it difficult to reach the full potential of digital health and patient-related data. An important and highly relevant initiative activated by the European Commission, the EHDS, is promised to overcome these obstacles.
The IMPROVE project was initiated to create an online platform that supports the development and implementation of integrated healthcare solutions using patient input, including RWD. This platform will drive scientific advancements by leveraging patient input and patient-generated evidence to accelerate the market entry of patient-centric, cost-effective integrated care solutions. By doing so, IMPROVE aims to enhance the return on research and innovation investments while promoting the sustainability of health systems.
Read more on www.multimedengineers.com/site/improve-ihi-project/
DKMA/DAC is contributing to WP7 and WP8 and supports developing tailored guidelines and interventions for policy recommendations while balancing local healthcare system needs and stakeholder-specific solutions, and also assists in implementing the Strategic Communication and Dissemination Plan to ensure effective communication of project outcomes to target audiences.
DARWIN EU
In May 2024, DAC was onboarded as a data node within the Darwin EU® (Data Analysis and Real-World Interrogation Network). The network is a European initiative coordinated by the European Medicines Agency (EMA). It serves as a platform to support the generation of high-quality real-world evidence for regulatory decision-making. The network connects healthcare databases across Europe, enabling the efficient and secure analysis of real-world healthcare data. In summary, Darwin EU® aims to transform how RWD are used in regulatory science, supporting evidence-based decision-making and promoting public health across Europe.
For in-depth information on key objectives and applications see Darwin EU®
Darwin EU® works with a growing network of data partners, including national and regional healthcare databases, research institutions and data custodians. The data remain securely managed within their respective locations, with analyses performed using federated approaches to ensure privacy and compliance with data protection regulations.
DAC is a Darwin EU® data Node and plays a pivotal role in facilitating the generation of real-world evidence to support regulatory decision-making across Europe. Leveraging Denmark's robust healthcare data infrastructure, DAC acts as a key contributor to the network’s objectives. This is done by enabling secure and efficient use of high-quality national Danish healthcare data including the Prescription Registry, Patient Registry, Vaccination Registry, Cancer Registry, Cause of Death Registry, Laboratory Results Registry via standardisation to the Observational Medical Outcomes Partnership (OMOP) common data model (CDM).
Within Darwin EU, DAC works closely with the EMA and other Darwin EU® data nodes to:
- conduct multi-database studies, sharing expertise and resources,
- provide insights into drug safety, utilisation and effectiveness studies that rely on real-world evidence, and
- act as a hub for Danish data contributions to multinational studies.
DAC thereby contributes to the continuous improvement of standards and practices for the use of RWD in pharmacoepidemiology.
DAC’s role as a data node strengthens the network by leveraging Denmark’s world-renowned healthcare data ecosystem, which is characterised by its completeness, accuracy and linkage capabilities.
Impact
Scientific papers
- Dudukina E, Brauner VE, Christiansen BC, et al. Associations between mRNA COVID-19 vaccination and urticaria: A nationwide registry-based cohort study in Denmark. Scandinavian Journal of Public Health, May 2025. https://doi.org/10.1177/14034948251333901
- Kønsrepræsentation i klinisk forskning, Sundhedsstyrelsen, January 2025. https://sst.dk/da/nyheder/2025/kønsrepræsentation
- Peltner J, Becker C, Wicherski J, et al. The EU project Real4Reg: unlocking real-world data with AI. Health Research Policy and Systems, February 2025. https://doi.org/10.1186/s12961-025-01287-y
- Pottegård A, Kristensen KB, Reilev M, et al. Existing data sources in clinical epidemiology: the Danish COVID-19 cohort. Clinical Epidemiology, August 2020. https://doi.org/10.2147/CLEP.S257519
- Sørensen AMS, Rasmussen L, Ernst MT, et al. Use of tramadol and other analgesics following media attention and risk minimization actions from regulators: a Danish nationwide drug utilization study. European Journal of Clinical Pharmacology, October 2020. https://doi.org/10.1007/s00228-020-03016-6
- Wested BJ.Chapter: Children rights in clinical trials, in Children Rights in Biomedicine in Europe: Protecting Children in Pursuit of the Highest Attainable Standard of Health. Cambridge University Press, June 2025. Accepted.
- Wested BJ. Chapter: Populations in clinical trials, in Douglas C, Geiger S, Kleinhout-Vliek T, Martin P, Wadmann S, et al. Science and Technology Studies (STS) Handbook of Global Pharmaceutical Biotherapeutics and Society Studies. Edward Elgar Publishing, 2024.
- Wested BJ. Lex Sex – Regulatory perspectives on the inclusion of males and females in clinical trials. European Health and Pharmaceutical Law Review, January 2024. https://doi.org/10.21552/ehpl/2023/4/6
Active contribution at the conferences
- Poster at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE), Halifax, Canada, 25-27 August 2023 - Wested J., Ala T., Bräuner E., Hallum S., Handest M., Mogensen S., Neglected populations in clinical trials- A pilot study of asthma medication use, comparing registered Real Word populations with Phase III clinical trial populations
- Poster at the 40th International Society for Pharmacoepidemiology (ISPE), Berlin, Germany, 24-28 August 2024- Dudukina E., Brâuner E., Mogensen S., Hervig M., Ulsø S., Larsen M.- Associations between the most recent mRNA COVID-19 vaccine dose and urticaria: A nationwide registry-based cohort study in Denmark.
- Organization of the mini conference Developing Policies for Neglected Populations (DePNeP), 17th May 2022, Faculty of Law, Karen Blixens Plads 14, 2300 Copenhagen
- Organization of the mini conference to finalize the project Representation in clinical trials REPACT- 25th April 2024, Danish Medicine Agency, Copenhagen
- Presentation at the Center for regulatory science (CORS) Annual Conference 2021, Copenhagen, 1 September 2021, Wested J. - Is there a legal requirement to address underrepresentation? – considerations on the “new” Clinical trial regulation and EMA strategy for regulatory science?
- Presentation at the Nordic Biomedical Law Conference, University of Bergen, Bergen, 22 November 2021, Wested J.- Representation in clinical trials. Overview of the regulatory landscape and an empirical study of asthma medicine.
- Presentation at the Utrecht Winter meeting, University of Utrecht, 11 January 2024, Wested J. - Lex Sex Regulatory perspectives on representation of sexes in clinical trials.
- Presentation at the Big data and AI, Conference, Copenhagen, 17 January 2024, Wested J. - AI in the medicinal product life cycle – Overview and perspectives on the EMA reflection paper.
- Presentation at the Medicon valley alliance – women’s health network, 5 March 2024, Wested J. - Lex sex – regulatory perspectives on the representation of women in clinical trials
Teaching
- 2022 – 2025: Teaching on DANIDA course offered by Center for Regulatory Science (CORS) – “Inclusion of special populations in drug development”
DARWIN studies
DAC contributes to all types of Darwin EU studies including:
- Off the shelf studies
- Routine Repeated studies
- Complex studies
- Very Complex studies
For a full list of all Darwin studies, including those DAC participates in please see here: https://www.darwin-eu.org/index.php/studies
