Background information
The number of clinical trial applications submitted in Sweden has declined sharply over the last decade. As pharmaceutical companies often make clinical trial allocation decisions based on previous studies in a country, a declining number of company-initiated clinical trials in Sweden leads to a negative spiral. In addition to the loss of research, the consequences can include reduced access to new and potentially better treatments for patients.
Challenge
Sirona Health Solutions has been commissioned by Region Skåne, through their collaboration with the Research and Innovation Council of Skåne (FIRS) and SmiLe Incubator, to conduct a feasibility study to identify key factors that can stimulate an increased number of company-initiated clinical trials in Sweden. The main questions of the assignment were:
- What infrastructural changes are needed to increase the potential for more clinical trials?
- What do regions and national actors need to do to become competitive?
Implementation
Data was collected through 30 focus interviews with various stakeholders involved in clinical trials and life sciences. The actors worked in the pharmaceutical industry, the Government Offices, authorities, regions, health care and industry organizations. Based on the interview responses, Sirona developed a model for a sustainable and scalable structure for the initiation and implementation of company-initiated clinical trials.
Outcome
The feasibility study resulted in a written report which identified key factors that can stimulate an increase in the number of company-initiated clinical trials in Sweden and a concrete basis with proposals on how these can be implemented in a scalable and nationally sustainable structure. In addition, three key barriers to conducting company-initiated clinical trials in Sweden were identified:
- Lack of mission and objectives
- Lack of soft infrastructure
- Unknown or insufficient study population
Based on this, Sirona provided recommendations for the most prioritized improvement actions. Due to the complexity of the problem, proposals for action were compiled at both national and regional level. These include recommendations on mission, objectives and follow-up, funding and reimbursement models, soft infrastructure conditions, marketing and profiling, and initiatives to increase the study population.
Final report.pdf
The feasibility study has been carried out within the Strategic Innovation Program Swelife, a joint initiative of Vinnova, Formas and the Swedish Energy Agency
