New action plan for clinical trials presented

The action plan is a sought-after continuation and follow-up of the National Action Plan for Clinical Trials 2021-2025. In the first plan, a number of measures were implemented to increase the number of clinical trials.

- Nevertheless, I receive feedback that there are challenges. Patients are requesting more opportunities to participate in clinical trials. For professionals, lack of time is the biggest obstacle, and local management reports that clinical research is still disconnected from regular governance and reporting. The activity is still too dependent on individual engagement. It takes too long to deliver data for research purposes, and we have not seen the development we desired in the number of industry-funded trials, says Vestre.

In the plan presented today, the government expands the vision: Norway should be among the most attractive countries in Europe for conducting industry-initiated clinical trials.

At the same time, they also expand the plan to encompass all clinical research, not just clinical trials.

Read the entire National Action Plan for Clinical Trials 2026-2036 (National Action Plan for Clinical Trials and Clinical Research 2026–2036 - regjeringen.no) (Norwegian).

The government sets new ambitious goals, with five focus areas and several indicators to monitor activity.

The five focus areas are:

1. Increased opportunities for patients to participate in clinical research
2. Conducting clinical research as an integrated part of healthcare service delivery
3. More collaboration between the healthcare service and industry
4. Efficient and safe conduct of clinical research through digital solutions
5. International collaboration and research preparedness

The government has three main initiatives to strengthen clinical trials and clinical research. They will:

1. Contribute to stronger incentives for clinical research in specialist healthcare through activity-based funding of clinical trials, as this will help integrate clinical research into clinical practice.
2. Increase the use of digital solutions, health data, and artificial intelligence to simplify and streamline research processes.
3. Implement measures for faster approval and conduct of clinical trials and clinical research, which will help make Norway more attractive to the health industry.

The government also has five goals for the period (2026-2036):

1. Annual increase in patients participating in clinical research
2. Top three in Europe for the number of clinical trials per million inhabitants
3. Doubled research full-time equivalents in clinical research
4. Increase in industry investments in research and development
5. Streamline the conduct of clinical trials through the use of digital solutions, registry data, and artificial intelligence.

- If we succeed, it will create value for patients and services, and for the sustainability, value creation, and preparedness of society, says Vestre.

Among the more concrete measures, both new and continued initiatives from the previous version of the action plan, the government wants to:

• Establish a real-time overview of clinical trials on helsenorge.no
• Launch a solution for digital consent on helsenorge.no
• Develop common guidelines for how the entire healthcare service can facilitate a more systematic assessment of patients' opportunities to participate in clinical trials
• Further develop the role of the health industry in NorTrials by mapping whether individual companies can contribute with funding and other forms of support
• Develop the NorTrials feasibility portal into a data-driven service to explore opportunities for conducting a relevant study based on patient demographics and capacity at relevant study sites.
• Facilitate the extraction of information from clinical systems for the selection of potential patients and the collection of systematically recorded patient information
• Facilitate increased use of artificial intelligence and synthetic control arms in the conduct of clinical research
• Strengthen Nordic cooperation between national health authorities on clinical research, including the use of health data