Clinical trials play a crucial role in advancing medical research and bringing new and innovative treatments to the market. The Nordic region is known for its strong life science research and development, as well as unique health data. Performing clinical trials in the region is not without its challenges, but these can be overcome through improved collaboration and new technologies.
One 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 of Medicon Valley Alliance (MVA), 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.”
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. There 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.”
“The issue is widely recognized and 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 and 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.
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.”
Marianne 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.
That means a lot, having such strong political backing.”
Additionally, Denmark has a national strategy for clinical trials and, like Sweden, has a strong tradition of collaboration between academia, industry and the healthcare system, which has enabled the country to attract many international clinical trials.
“The life science industry is (in 2022) about 22 percent of Danish exports. It’s a very strong industry in Denmark, with solid traditions and with some of the organizations being Foundation-owned thereby providing stability in ownership. There has been strong political backing over a number of years. And, of course, that means a lot, having such strong political backing. This focus on life science and health is expressed in the new government’s main policy objectives,” explains Pilgaard further.
Collaboration and new technologies
By working together, the Nordic countries could, in theory, share their knowledge and resources, and standardize the regulatory process across the board, making it easier for companies to navigate, and in turn, make better use of the region’s unique health data and genetic research. Iceland, for example, has a unique population with a high degree of genetic homogeneity, making it an ideal location for genetic research and clinical trials. Iceland could leverage its unique data and expertise through increased collaboration.
New technologies and concepts, such as decentralized trials and new recruitment methods using modern digital tools, can also play a role in overcoming these hurdles.”
New technologies and concepts, such as decentralized trials and new recruitment methods using modern digital tools, can also play a role in overcoming these hurdles. Decentralized trials can make it easier to recruit patients in remote areas and telemedicine can streamline the recruitment process and improve patient engagement.
This use of technology is something Steenberg feels strongly about, saying virtual trials “could accelerate the process of doing more joint trials and expanding the cohorts”. Both to be able to do more trials, and also to make it easier for people to participate in the trials. “I see this as a win-win opportunity for both patients and companies,” she says.
Kolehmainen agrees that the technology will play an important role in recruitment, highlighting that the Nordics are relatively small countries, and especially with trials on rarer diseases, it might take a lot of work to find enough suitable subjects. “Here modern tools, like our CliniScout Recruit, help, utilizing digital means to accelerate and boost recruiting,” he says.
Talent goes hand in hand with R&D
Another important factor in the growth and success of the clinical trials industry in the Nordic region is the ability to attract and retain talent. The industry requires highly skilled professionals, including doctors, nurses, and researchers, to successfully conduct and manage clinical trials. By creating a strong and efficient clinical trial industry, the Nordic region can attract top talent from around the world.
“When you look at the life sciences in this region, it represents a multitude of different nationalities. We have too little Scandinavian talent in order to sustain the continuous growth of the life science sector. Companies look for areas where there is a critical life science talent pool, talent looks for world-class research that happens in academia and in companies – getting this right creates a virtuous circle,” says Steenberg.
This is also why we must keep the R&D and innovation in our countries because of the critical talent pools that we do have and produce, but we need to attract more because we don’t have enough.”
The importance of talent goes hand in hand with R&D and Steenberg emphasizes how important this is for the region. “We have a lot of R&D and it is extremely important that this area of the world is focusing on R&D. These are valuable jobs. We do already have a lot of joint cross-border projects within R&D. It’s a greater part of the value chain than just clinical trials,” she says.
“By joining forces across the border, there’s no doubt, we can have a critical mass that can attract more investors and, most importantly, more talent. This is also why we must keep the R&D and innovation in our countries because of the critical talent pools that we do have and produce, but we need to attract more because we don’t have enough,” she adds.
Overcoming the hurdles
The Nordic region has a strong life science industry, unique health data and resources, and well-functioning healthcare systems, however, the lack of standardization in the regulatory process and patient availability shows there are challenges.
Petteri Kolehmainen suggests that the hurdles can be overcome by increasing collaboration between countries, improving regulatory harmonization, and providing support for recruiting patients.
The Nordics traditionally are very good with new technologies, this brings additional opportunities for us here.”
The use of new technologies like decentralized trials, telemedicine, and virtual trials, can streamline the recruitment process, increase patient engagement and make it easier for people to participate while leveraging unique health data and expertise, while also attracting future investment.
“The new technologies will help to speed up studies, save costs, and help find and keep the patients. More simply, the Nordics traditionally are very good with new technologies, this brings additional opportunities for us here,” concludes Kolehmainen.