Teaser about what is possible with Danish RWE studies
05 Jan 2023

Access to rich high-quality data for RWE-studies can provide insights beyond what is typically feasible in traditional clinical trials. Denmark has a rich real-world-data environment that allows for linkage between different registries that has been used extensively in research. See previous blog-post for more info.

If you are interest to learn more about the opportunities with Danish Real-World-Evidence, don’t miss our upcoming webinar, January 17th.

Here are few examples from Denmark that illustrates what may be possible:

  • Analysis of cardiovascular risk of Diclofenac leads to change in guidelines and changed regulatory indication
    Through a series of 252 nationwide emulated trials including several million drug initiators, it was possible to determine that Diclofenac poses an undue cardiovascular risk in relation to existing comparators. This is now reflected in international guidelines and led to withdrawal of over-the-counter sales in some countries.
    Schmidt, Morten, Henrik Toft Sørensen, and Lars Pedersen. ‘Diclofenac Use and Cardiovascular Risks: Series of Nationwide Cohort Studies’. BMJ 362 (4 September 2018): k3426. https://doi.org/10.1136/bmj.k3426 .
     
  • Ruling out relevance to search for hidden cancer in patients with deep venous thrombosis or pulmonary embolism
    The ability to use analyse the complete national cohort over a period of 15 years allowed the researchers to resolve the controversial question.
    Sørensen, Henrik Toft, Lene Mellemkjær, Flemming Hald Steffensen, Jørgen H. Olsen, and Gunnar Lauge Nielsen. ‘The Risk of a Diagnosis of Cancer after Primary Deep Venous Thrombosis or Pulmonary Embolism’. New England Journal of Medicine 338, no. 17 (23 April 1998): 1169–73. https://doi.org/10.1056/NEJM199804233381701 .
     
  • Evidence of how the standard of care for myocardial infarcts drastically improve
    The study includes 234 331 patients with first-time myocardial infarction over a period of 25 years to understand the trends in incidence and prognosis, giving essential insight to how HealthCare delivery has improved.
    Schmidt et al., “25 Year Trends in First Time Hospitalisation for Acute Myocardial Infarction, Subsequent Short and Long Term Mortality, and the Prognostic Impact of Sex and Comorbidity.”
  • Registries are utilized for automatic event detection in pragmatic trials.
    The ability to link different data-sets, including clinical trial data, enables the use of the real-world-data sets to capture the events of interest and thus significantly reducing the cost of trials.
    Maeng, Michael, Hans Henrik Tilsted, Lisette Okkels Jensen, Lars Romer Krusell, Anne Kaltoft, Henning Kelbæk, Anton B. Villadsen, et al. ‘Differential Clinical Outcomes after 1 Year versus 5 Years in a Randomised Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Coronary Stents (the SORT OUT III Study): A Multicentre, Open-Label, Randomised Superiority Trial’. The Lancet 383, no. 9934 (14 June 2014): 2047–56. https://doi.org/10.1016/S0140-6736(14)60405-0
     
  • Feasibility to carry out long-term follow up allows for study that questions previous perspective about feasibility to use 1-year follow up to predict 5-year outcomes
    Utilizing the ‘ease’ to do long-term follow-up the researchers demonstrate that the traditional 1-year primary endpoint may be insufficient.
    Maeng, Michael, Hans Henrik Tilsted, Lisette Okkels Jensen, Lars Romer Krusell, Anne Kaltoft, Henning Kelbæk, Anton B. Villadsen, et al. ‘Differential Clinical Outcomes after 1 Year versus 5 Years in a Randomised Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Coronary Stents (the SORT OUT III Study): A Multicentre, Open-Label, Randomised Superiority Trial’. The Lancet 383, no. 9934 (14 June 2014): 2047–56. https://doi.org/10.1016/S0140-6736(14)60405-0
     
  • Extensive and broad use in pharmacoepidemiological research
    210 publications in pharmacoepidemiological using Danish real-world-data in broad variety of indications and types of outcomes.
    Petersen, Charlotte Thor, Kristoffer Jarlov Jensen, Mary Rosenzweig, Benedikte Irene von Osmanski, Mikkel Zöllner Ankarfeldt, and Janne Petersen. ‘Mapping Outcomes and Registries Used in Current Danish Pharmacoepidemiological Research’. Clinical Epidemiology 14 (26 April 2022): 521–42. https://doi.org/10.2147/CLEP.S341480

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