Nordic Life Science 1
52 O NE HURDLE FOR CLINICAL TRIALS in the Nordic
region is the lack of standardization in the regulatory process across the different countries. As Anette Steenberg, CEO, Medicon Valley Alliance, a non-profit membership organization in the Medicon Valley Danish-Swedish life science cluster says, “We have different ways of going about clinical trials [in the Nordics], and if there was one single way of doing it, of course, that would have been much easier. We are not aligned, which makes it more difficult to do major studies together, not impossible, but difficult.” With each country having its own set of rules and regulations, it can be difficult to navigate regulatory processes and obtain approval for any potential trials, which can result in delays and increased costs. Petteri Kolehmainen, Managing Director of Healthware for the Nordics and Baltics, based in Helsinki, also acknowledges this problem. “The countries in the region work under the same or similar regulations but interpret the legislation differently. here are minor differences between what ethical committees approve and what specific methods and technologies are currently allowed,” he says. Denmark is seen as one of the leading Nordic nations for clinical trials. It was the first country to offer a single national entry point for life science companies to perform clinical trials, explains Steenberg. “So, because of the single entry point, it just makes it much faster and easier. It’s not cheap in for instance the US either, or any of the Nordic countries, compared to other countries. However, the speediness and the quality of the output is very high,” she says. “The issue is widely recognized but there are initiatives trying to promote better collaboration in the Nordics, like the Nordic Trial Alliance (NTA), which targets clinical research collaboration and multi-site management in the Nordic region, or Nordic Health Research and Innovation Networks promoting better clinical practice,” Kolehmainen explains, showing work is being done to address some of these issues. Small populations – challenges & strengths The limited number of patients is another obstacle for clinical trials in the region. Small population sizes in the Nordics can make it challenging to recruit sufficient numbers of patients, particularly for rare diseases, which can result in delays in the completion of trials and impact the ability to gather significant data. On the other hand, this can be a strength. Iceland, for example, is known for its unique health data and genetic research. “Iceland has an amazing cohort population. It is a very tiny one, but is very, very interesting in terms of performing clinical trials there,” says Steenberg. M Petteri Kolehmainen, Managing Director Nordics and Baltics, Healthware Group arianne Pilgaard, CEO of Trial Nation, agrees a country’s size can have both benefits and drawbacks. “Denmark is a small country population-wise, and we have a well-functioning healthcare system. A lot of the ongoing development of new products is more and more focused on very specific small patient populations and we are very good at finding those,” she says. A national strategy for clinical trials Trial Nation, a non-profit public-private partnership organization, is an example of why Denmark is at the forefront in the Nordic region when it comes to clinical trials. The organization is member-based and includes the Ministry of Industry, Business and Financial Affairs, the Ministry of Health, and the five Danish Regions members representing the Danish healthcare system and the Danish State. Additionally, Denmark has a national strategy for clinical trials and, like Sweden, has a strong tradition of collaboration between academia, industry and the HEALTH // CLINICAL TRIALS