Denmark Offers One-Stop-Shop For Clinical Trials
Denmark Is Actively Wooing Businesses That Depend On Clinical Trials
Executive Summary
Denmark’s Trial Nation Portal was established in 2018 with government backing and the aim of luring clinical trials to the country.
Denmark has become the envy of its Nordic neighbors by building a joined-up “one-stop-shop” approach to attract pharma companies to the small Scandinavian country to conduct their clinical trials.
The initiative – called Trial Nation – was founded last year with the backing of regional and state government and from a group of Danish life sciences companies. It offers a single, national entry point for biopharma companies, patient organizations and clinical researchers wanting to sponsor, participate in, and conduct clinical trials in Denmark.
It took just four years to create Trial Nation, a process that benefited from a strong desire within the country’s government and parliament to boost Denmark’s life sciences industry, which already benefits from a thriving medical and academic ecosystem. The assumption is that a single point of entry helps to better identify relevant subjects and facilitates contact with leading clinical centers of excellence at Danish hospitals nationwide.
Public-Private Cooperation
An important component for this project is the public ownership of universities and university hospitals in Denmark, which presents big possibilities for the integration of research and clinical care. It is further supported by substantial public and private investment in medical research in universities and industry.
Another key factor is that many large Danish companies are foundation-controlled – a unique ownership model, whereby a founder irrevocably donates the majority of shares in a company to an independent legal entity, called a foundation, with certain rights and responsibilities. No person or legal entity will thereafter own the foundation’s assets and the foundation needs to have a non-selfish purpose. The foundation typically maintains control over the company.
Two thirds of all listed companies in terms of value on the Danish Stock Exchange are of this type, including the four biggest life science companies: Novo Nordisk A/S, LEO Pharma A/S, Lundbeck A/S, and Coloplast A/S.
Big data and its collation nationwide is another advantage for Denmark. The country has electronic health care data going back more than 40 years, bolstered by 170 clinical databases and the Danish Biobank Register, which connects 25 million biological samples.
Denmark’s Life Sciences Sector By The Numbers
The Danish life sciences industry comprises almost 1,500 life sciences companies and about 47,300 employees.
Life sciences companies account for more than a third of all private research and development projects in Denmark.
Life sciences investments in Denmark have grown by 60% since 2008.
Subsidiaries of major international life sciences companies employ more than a quarter of all employees in the Danish life sciences industry.
The result is a life science industry that today generates more than 17% of Denmark’s total export of goods. The sector’s ambition – supported by government policy – is to double that export contribution by 2025. Integral to that aim is attracting more clinical trials to the country.
Denmark’s share of applications for clinical trials within the EU increased from 9% in 2015 to 12% in 2017. The Danish Life Science community and government hope Trial Nation – which opens doors to labs and clinics throughout Denmark – can help maintain that momentum.
There are currently 384 recruiting clinical trials occurring in Denmark. Their details can be found at ClinicalTrials.gov. Many are being conducted by companies not headquartered there, including AbbVie, AstraZeneca, Boehringer Ingelheim, MSD, Novartis, Pfizer, Roche and Sanofi.
Switzerland-based Roche said the Trial Nation approach should help to push for better timelines. “This initiative also creates an awareness of the importance of clinical trials which does make life easier for companies," said Nicolas Dunant, head of media relations at the Swiss drugs group, told In Vivo.
Although it is still early days for the Trial Nation project, Roche is optimistic that it will be a success.
“This is a long-term initiative where we work on simplifying, standardising and approving things. Having the private-public partnership and the governmental involvement and support does make things much easier,” Dunant said.
By attracting clinical trials to Denmark, the stakeholders behind Trial Nation hope to continuously provide patients at Danish health care facilities with state-of-the-art treatments. The portal’s services include investigator identification, a coordinated feasibility process with a national response from hospital sites within five days, estimation of patient numbers eligible for a specific trial and access to established partnerships with hospitals, scientists and patient networks – all free of charge.
At present, there are Trial Nation centres in operation for oncology and hematology, dermatology, respiratory diseases, infectious diseases and dementia. Additional research centres are in the pipeline.
The Danish Medicines Agency has set a goal to process all clinical trial applications within a maximum of 30 working days, corresponding to 42 calendar days. On average, more than 90% of all trial applicants receive a first reply within 42 days – around 95% of applications are accepted, according to Trial Nation.
Denmark’s single-entry testing hub was the result of a four-year public-private partnership called the National Experimental Therapeutic Partnership (NEXT) and its merger in 2018 with the country’s state-owned regional service clinical trials office. Britta Smedegaard Andersen, an experienced clinical trial manager, was NEXT’s project director and a driving force behind the initiative. She said that Danish government backing had been crucial for the project’s advancement.
“NEXT was started in 2014 and ended in 2018 when its activities were passed to Trial Nation, which is now a state-funded initiative, single port of call for industry to come to in and organize clinical trials in Denmark,” she told In Vivo. “The involvement of the Danish state in this was key, and means the government wants to be involved in the life science strategy for Denmark going forward,” Smedegaard Andersen said.
An Enviable Setup
Trial Nation is a Danish success story that neighboring countries clearly envy.
“All the Nordic countries are studying what we’re doing in Denmark because somehow we’ve succeeded in joining the various ends and making it happen using the public-private approach to attract more clinical trials here,” Smedegaard Andersen said. It would be in Denmark’s interests if similar initiatives could be set-up in Sweden and Norway, as that could bring “critical mass” to the region in the form of expertise and infrastructure, she added.
Such a development is not likely anytime soon, however. Norway’s life sciences sector is not yet adequately advanced for an initiative like Trial Nation.
In Sweden, the national life sciences sector is highly efficient and innovative, but the central government has not made promoting clinical trials a distinct policy objective. Sweden’s position is that such an activity should be led by academic institutions and regional hospitals, which in turn say they are already overstretched and underfunded.
Smedegaard Andersen said this should leave the field open for Denmark’s regional play for attracting clinical trials. “We would like to have a bigger Scandinavian initiative in future, because Denmark is such a small country. But that won’t be possible until each of the Nordic countries are sorted on the national level. That’s what they are struggling with in Sweden, for example,” Smedegaard Andersen said.
“Sweden’s regional university hospitals and the Karolinska Institute are top quality and doing very well independently, but they are having difficulties taking the broader national view.”
Sweden Still Side-Lined
Clinical trial expert Arvid Soderhall says making that happen in Sweden will take time and necessitate a number of changes to occur first.
“I authored a report and project in 2014 at the Royal Academy of Engineering Sciences which was very much inspired by what was going on in Denmark. It got some traction within the Swedish government, but it did not go very far,” Soderhall told In Vivo.
He said lack of commitment from central government in Sweden was a major stumbling block to getting a joined-up approach to attracting more clinical trials to the country.
“The decline in the number of clinical trials being conducted in Sweden is seen by the central government as being essentially an academic problem for academics to sort out, not an economic problem that’s is undermining the life sciences sector’s overall contribution to the national economy,” said Soderhall.
That is not the only barrier, however. “We are in discussions in Sweden between the pharma industry and the regional hospitals aimed at promoting cooperation within clinical trials. But these efforts are being hindered by a number of factors, one of which is a long-standing lack of trust between the two sides, which goes back many years,” Soderhall explained.
“We are now trying to build up trust again between the two sides with the hope of creating cooperation between the two sides and ideally to the extent that we’re seeing in Denmark right now. But that will take time.”