Over the past 30 years, clinical research within the Nordic region has been on the wane.[1] Against that backdrop, a collaborative project, involving the Nordic countries, was established by the Nordic Council of Ministers to tackle the enduring problem. The Nordic Trial Alliance – a three-year initiative run from 2013-2015 – was designed to encourage clinical research while fostering greater collaboration between Nordic countries. But since the NTA drew to a close, clinical trial activity has thrived in some countries but dwindled in others. Below is a brief overview of clinical trials in the Nordic region.
Denmark
In the Nordic region, Denmark dominates with 335 studies in 2015.[2] A majority of those trials were Phase III studies (129), while 106 trials were in Phase II, 71 were Phase IV, and 29 were Phase I. While the Danish Medicines Agency assesses the safety and efficacy of clinical trials, a research ethics committee must also be on hand to evaluate the ethics of the studies. Prior to the start of any clinical, sponsors must gain approval from both the Danish Medicines Agency and a research ethics committee.[3]
In the past, clinical trial applications has ebbed and flowed as the number of industry sponsored trials and academic studies varied from year to year. From 2007 to 2011, academic research rose by 86 percent compared to a decrease of 26 percent in industry sponsored clinical trials. Additionally, in the intervening years, a trend emerged where more trial participants signed up for academic trials than studies by industry sponsors. Some of that could be owed to the fact that roughly 60 percent of the clinical trials at the time were multinational studies with many taking place outside of Denmark.
Sweden
As a country, Sweden has had a strong background in clinical research, with experts attributing that success to partnerships formed between industry, universities and healthcare organizations.[4] In 2015, Sweden initiated 305 trials with 146 studies in Phase III. Additionally, there were 102 Phase II trials, 43 were in Phase IV and 14 in Phase I. The Medical Products Agency, Läkemedelsverket, is the competent authority that approves clinical trials of both medicinal products and medical devices. In order to begin a trial, however, the proposed study must gain further approval by the relevant Board of Ethics Review.[5] To obtain marketing authorisation for a medicinal product, the process approximately takes one year (210 days).
Finland
Over the years, Finland has established itself as a prime location for vaccine clinical trials.[6] In 2015, the country had initiated 152 trials, with 109 Phase III studies, 34 in Phase IV, six in Phase I, and three in Phase II. Fimea, the Finnish Medicine Agency, is the main regulatory body that oversees clinical trial applications of medical products. Similarly, the National Supervisory Authority of Health and Welfare, Valvira, is the competent authority on all regulatory matters concerning medical device clinical trials. For the ethical admissibility of clinical trials, submissions are evaluated by TUKIJA, the National Committee on Medical Research Ethics.[7]
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Norway
Overall, clinical trial activity in Norway appears to be in steady decline. In 2011, 69 percent of clinical trials were industry sponsored compared to 55 percent in 2015.[8] Overall, 101 active studies took place, 64 of which were Phase III studies, 27 were Phase IV, five were Phase I and an additional five were in Phase II. Applications for clinical trial approval are encouraged to be submitted electronically to the Norwegian Medicines Agency.
Iceland
Among the Nordic countries, Iceland started the fewest number of trials in the region with six active studies in 2015. There were three trials in Phase III, two in Phase II, one in Phase IV, and zero in Phase I. Clinical Trials applications are handled by the Icelandic Medicines Agency. In 2016, the Icelandic Medicines Agency, Lyfjastofnun, has so far approved four clinical trials.
Out of all the Nordic countries, Denmark initiated the highest number of clinical trials with Sweden on its coattails. According to a white paper by GlobalData, 674 clinical trials across the region were initiated in 2015 with oncology the top therapeutic area. Over 50 percent of studies that year were sponsored by pharmaceutical companies compared to academic institutions, indicating pharma remains a force to be reckoned with. However, a closer inspection of the numbers reveals that Phase IV studies were largely academic-sponsored while Phase I and Phase III trials were mostly conducted by industry sponsors.
PHOTO CREDIT: Nicolas Raymond via www.freestock.ca
References
[1] GlobalData – The Latest Trends in Clinical Investigation in Nordic Countries, 2015
[2] GlobalData – The Latest Trends in Clinical Investigation in Nordic Countries, 2015
[8] GlobalData – The Latest Trends in Clinical Investigation in Nordic Countries, 2015
