For a growing number of the world’s major life science companies, Denmark is the ideal location for conducting clinical trials within personalised medicine.

One of the reasons is the Danish single national entry point to clinical trials, Trial Nation. Trial Nation is a Danish publicly funded, non-profit organisation and is a result of strong and continuous governmental support of the Danish life science sector. The organisation offers a single, national entry point for global companies, looking to conduct clinical trials in Denmark, and all the services are free of charge.
The Ministry of Industry, Business and Financial Affairs, the Ministry of Health, several Danish life science companies and the Danish Regions (the regions are responsible for the hospitals in Denmark) fund Trial Nation. 

Trial Nation is working with all University Hospitals in Denmark. The organization relay feasibilities within all disease areas to all Danish clinical trial units and support the clinical trial infrastructure in approximately 40 clinical trial units across Denmark. Trial Nation also hosts regular partner meetings and coordinates a CRO-network of approximately 20 members.

Furthermore, Trial Nation collaborates with various stakeholders on framework conditions for clinical trials in Denmark including dialogue forums with health authorities and industry associations. Topics include all aspects of clinical trials and decentralised clinical trials has a special focus.

One of the clinical trial units of Trial Nation works extensively with a Phase 1 Unit at Copenhagen University Hospital (Rigshospitalet).The Phase 1 Unit is a dedicated experimental clinical oncology department with specific focus on phase I and early phase II trials. Since 2013, the Phase 1 Unit have introduced a personalised genomic screening program. 

The Phase 1 Unit, which receives patients from all areas of Denmark with no other treatment options, has since 2013 introduced a personalised genomic screening program to its patients. Since 2021, the screening program is implemented at all hospitals in Denmark due to the establishment of the National Genome Centre. 

The Phase 1 Unit has established a virtual national tumour board, which meets once a week. Apart from clinical oncologists, the board also consist of specialist within Molecular Biology, Genomics, Clinical Genetics, Bioinformatics and Pathology. The tumour board reviews clinical status of patients with specific genomic alterations that potentially drive tumour growth that can be targeted with drugs in development. The board then defines the actionable targets and suggests a treatment within available and ongoing clinical trials as well as within the network of Trial Nation. The Phase 1 Unit collaborates with other Nordic and European phase I units.

In Denmark, the National Committee on Health Research Ethics makes guidelines for projects involving genomics research and research in sensitive bioinformatics data, such as whole genome- and exome sequencing, RNA sequencing and genome-wide association studies. The purpose of these guidelines is to ensure that genomics research takes place according to the provisions of the Committee Act in relation to research participants’ autonomy, safety and well-being.

The guidelines also instruct that in cases of secondary findings, support from a committee of clinical genetic experts to assist with these incidental findings is necessary. A secondary – meaning a finding unrelated to the project’s purpose that reveals a participant having an unexpected high degree of probability to be predisposed to a life-threatening disease – is found in approximately 3% of a study population. The finding is often related to cancer susceptibility or cardiac diseases.

The Department of Clinical Genetics at Rigshospitalet has developed a general model for collaboration for clinical trial sponsors to use in order to secure a safe and acceptable handling of genome analysis and incidental findings. The National Committee on Health Research Ethics supports this model. 

The Department of Clinical Genetics at Rigshospitalet collaborates with both public researches and private pharma-companies. A contract and transfer agreement is made when collaborating with pharma-companies. 

This article is based on a webinar on clinical research for personalised medicine hosted by Invest in Denmark at the Ministry of Foreign Affairs of Denmark and the Danish Association of the Pharmaceutical Industry in spring 2021. 

Watch the entire webinar on-demand or download speaker presentations
Clinical research for personalized medicine in Denmark (investindk.com)

This webinar was the third episode out of a four part webinar series on personalised medicine – from basic research to post-marketing activities. Each episode provided an overview of the Danish research infrastructure within a specific phase of the drug development process. 

Watch the entire webinar series on-demand or download speaker presentations
Webinar series on personalized medicine in Denmark (investindk.com)

If you want to know more about, why Denmark is the right place in Europe for clinical trials please read our business brief. 

Download business brief: Denmark - the place in Europe for clinical trials (investindk.com)