Clinical Trials in Nordic Countries

In 2012, the number of clinical studies conducted in the Nordic countries was on the decline; they had been for decades. Many clinical studies were instead being carried out in other countries, where costs were lower and there were a far larger patient base available compared to the Nordic countries

The worry was this decline would not only have potentially negative consequences for the Nordic countries’ international position in medical research, but that it could also lead to a situation in which Nordic patients are no longer guaranteed access to the latest treatment methods.

To work toward a cooperative solution, The Nordic Trial Alliance, a three-year pilot project funded by Nordic Council of Ministers’ and NordForsk in 2013, was designed to increase cooperation on multi-center clinical trials in the Nordic countries.

The Nordic Trial Alliance was established to counter the decreasing trend in clinical studies. The initiative’s main objectives were to strengthen Nordic collaboration by disseminating information and refining existing initiatives on clinical research. It was designed to encourage clinical research and foster greater collaboration between Nordic countries.

Regulatory Frameworks

Nordic countries have similar regulatory frameworks. The basic operating principles and functions of ethics committees in all Nordic countries are very similar. With the exception of Iceland, ethics committees in Nordic countries are regional. The countries vary as to whether these tasks are assigned to regional ethics committees alone or divided among regional and national committees.

In addition to varying ethics committees, the documents required for ethical review depends on the country. For example, the number of required documents ranges from eight in Norway to 17 in Finland to 12 in Sweden. For a full list of the documents required for ethical review (by country), click here, and refer to Appendix 1.

Focus on 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. The Medical Products Agency, Läkemedelsverket, is the authority that approves clinical trials of both medicinal products and medical devices. In order to begin a trial, the proposed study must gain further approval by the relevant Board of Ethics Review. To obtain marketing authorization for a medicinal product, the process approximately takes one year (210 days).

There are six regional ethics committees reviewing both medical and non-medical research on humans in Sweden. The committees are appointed by the Ministry of Education and Research and operate in universities in Gothenburg, Linköping, Lund, Stockholm, Umeå and Uppsala.

In addition to the regional ethics committees, there is a Central Ethical Review Board (CERB), located in Stockholm. The CERB is responsible for making decisions on controversial issues submitted to it by the regional ethics committees and for serving as an appeal body for applicants who want to contest a decision made by a regional committee. In addition to reviewing appeals and referrals, the central board has a supervisory function.

The Future of Clinical Research in Nordic Countries

Given the need (and desire) to increase the number of clinical trials in the Nordic region, many in the clinical trial space believe the Nordic Trial Alliance was just the start of a Nordic collaboration on clinical research. Moving forward, the region needs to continue to build on the work that has been done during the pilot program.

According to a report published by Dove Medical Press in 2015, merging data from all Nordic countries allows for studies of rare exposures or outcomes in the large study population of more than 25 million people combined. Other examples of unique Nordic research could be comparing and evaluating differences between the Nordic countries such as policies/recommendations of medications use, incorporation of new medications and changes in vaccination programs.

Denmark, Finland and Sweden are part of the EU and will therefore be affected by the proposed EU general data protection regulation. This initiative is an effort by the European Commission to enforce a unified data protection framework for all member states in the EU. The report, “Ethical Aspects of Registry-based Research in the Nordic Countries,” says the current version of the regulation stipulates that research use of registry-based healthcare data does not require informed consent from all study participants. It states: “Should the next generation of the EU general data protection regulations require individual informed consents, truly population-based studies would no longer be possible in Denmark, Finland or Sweden.”

Expert Knowledge

Local market knowledge and working with language service providers with experience in the clinical research industry are key components of successful translations in Nordic countries. Contact Welocalize Life Sciences for information on how we can help sponsors and CROs translate clinical and regulated materials that are accurate, compliant and resonate with the local, target audience.

Resources

Regulation (EU) No 536/2014 on Clinical Trials

Ethical aspects of registry-based research in the Nordic countries

CROs in Denmark

CROs in Finland

CROs in Sweden

CROs in Iceland

Site Selection in Europe (A KPMG report)