Nordic Health Registers as a Source for Value-Based Evidence
- Olav Flaten
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The study and approval of new drugs for use in humans has historically been based on three elements: safety, efficacy and quality. Towards the end of last century, different biomarkers and surrogate endpoints were considered appropriate for documenting new treatments. Most of our therapeutic progress during this period was developed within that viewpoint, and has been implemented in healthcare with great success. However, when it became harder and harder to demonstrate superiority of new drugs over existing therapies, combined with increasing healthcare costs, new needs came to the surface. The validity or appropriateness of surrogate endpoints was challenged, and the requirement to demonstrate value to society, in addition to safety, efficacy and quality, has become the new standard. A value proposition for new drugs will include focus on hard endpoints such as survival, but also longitudinal data on the patient’s life and the societal impact of their disease. In the Nordic countries, and also in the UK and other European countries, there is an increasing interest in using health and quality registers to establish this new type of evidence. A few examples out of the vast number of registers are presented, to illustrate their potential as a valuable source of knowledge.
- Aalen OO. Armitage lecture 2010: Understanding treatments effects: the value of integrating longitudinal data and survival analysis. Stat Med. 2012;31:1903–17. CrossRef
- Frobert O, Lagerquist B, Olivecrona GK, et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013;309:1587–97. CrossRef
- Norwegian University of Science and Technology. The HUNT study—a longitudinal population health study in Norway. http://www.ntnu.edu/hunt. Accessed 15 May 2014.
- National Institute for Health and Welfare (THL). Kansallisen narkolepsiatyöryhmän loppuraportti. 2011. http://www.thl.fi/thl-client/pdfs/c02a3788-a691-47a4-bca8-5161b6cff077. Accessed 15 May 2014.
- European Centre for Disease Prevention and Control. Narcolepsy in association with pandemic influenza vaccination: a multi-country European epidemiological investigation. http://www.ecdc.europa.eu/en/publications/publications/vaesco%20report%20final%20with%20cover.pdf. Accessed 15 May 2014.
- Håberg SE, Trogstad L, Gunnes N, et al. Risk of fetal death after pandemic influenza virus infection and vaccination. N Engl J Med. 2013;368:333–40. CrossRef
- Food and Drug Administration. Approval letter - human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm111283.htm. Accessed 15 May 2014.
- Innovative Medicines Initiative. EHR4CR: electronic health records systems for clinical research. http://www.imi.europa.eu/content/ehr4cr. Accessed 15 May 2014.
- Nordic Health Registers as a Source for Value-Based Evidence
Volume 28, Issue 3 , pp 119-122
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- Springer International Publishing
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- Olav Flaten (1)
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- 1. Hunemo AS, Ovre Ullern terrasse 3C, 0380, Oslo, Norway