More company-initiated clinical trials!
In Sweden and the rest of the Nordic region there are, in many cases, unique conditions for clinical trials. We have excellent medical research and healthcare, innovative companies, registries and biobanks, but also a population with high trust in authorities, research and innovation. The parts are there, but the well-oiled machinery is missing. When actors step in with creative solutions and as coordinators of the systems, opportunities are created that produce good results, but the system is difficult to navigate for those who do not have the contacts or experience.
Cutting-edge or comprehensive mass study – different worlds
The conditions for clinical trials differ between studies in different phases. Phase I and II studies are specialized to determine properties, safety and efficacy in small groups of individuals. Phase III, on the other hand, involves studies in large groups of patients, based on the results of previous phases.
Business trials increase but decrease in Sweden
The Swedish Drug Discovery and Development Pipeline 2020 shows that half of the drug development companies’ trials are located outside Sweden and another quarter in both Sweden and abroad. It is not only the large phase 3 studies that require extensive patient data that are located outside Sweden, but also a large part of the phase 1 and 2 studies.
It is time to reverse the trend
The trend of a decreasing number of clinical trials taking place in Sweden has been going on for more than 10 years.
In order for Sweden to regain its attractiveness for company-initiated clinical trials, collaboration between industry, academia and the public healthcare system needs to be further strengthened.
“Administrative structures have the ability to counteract the political ambitions they are designed to address.”
– It is a stated ambition that Sweden should be a prominent life science nation and that the number of clinical trials should increase. Regulators are an important piece of the puzzle and need to be attractive both in terms of fast and smooth processes and a reasonable and competitive price tag. Otherwise, the political system risks biting its own objectives in the tail.
Frida Lawenius, Vice President SwedenBIO
“I would like to see us build on this positive solution-oriented drive, where we collaborate between different actors to remove unnecessary administrative barriers to conducting clinical trials. “
– A clear need that we see now is how we can facilitate with digital tools and perform the work remotely. To develop this, we need collaboration between healthcare, academia, industry and the agency, but also with actors outside the usual circle, who have other important knowledge.
Eva Löfkvist, Head of Clinical Operations Nordic, BMS and SwedenBIO’s representative in SKR’s cooperation group for clinical trials.
“Healthcare professionals’ understanding of how a drug gets from idea to market has increased and contributes to the willingness to participate in industry-sponsored drug trials.”
– I think this is good for publicly funded care and I hope that the principals can appreciate this. I would like to award a small gold star to the country of Sweden for the smooth running of clinical trials.
Arvid Söderhäll, CEO Empros Pharma
“To make it easier for businesses and researchers, it is important that authorities are transparent and that the basis for decisions is consistent over time.”
– It is very good that the Medical Products Agency offers the possibility of advice and it is my hope that this possibility remains at a low cost and with reasonable timelines.
Marie Gårdmark, CEO RegSmart
“Effective ‘matching’ between drug developers and clinics provides the conditions to attract groundbreaking treatment concepts to Sweden already in the development phase.”
– The Danish “Trial nation” model of a coordinated, free and fast matching process is a recipe for success that shows how we can get there. In the fierce international competition for trials, a “Trial Scandinavia” could bring Nordic countries together!
Thomas Olin, CEO Kancera
“To increase company-initiated clinical trials, clearer objectives and better conditions for soft infrastructure are needed”
– One of the most important measures we have identified to reverse the negative trend is to specify targets and ensure structures to continuously monitor targets and activities. Since there are currently no clear goals for clinical trials, this and centralized control are considered to have a major impact on shifting resources to trials to partially establish the soft infrastructure required to run clinical studies..
Shadi Abbas, Sirona Health Solutions
Read Sirona’s feasibility study on key proposals that can stimulate an increased number of company-initiated clinical trials in Sweden:
“We welcome all kinds of questions, not least from the companies connected to SwedenBIO.”
– Much of the innovative development takes place in your companies, and in order for us to be able to further develop ourselves and the regulations, we need to be challenged by your questions.”
Gunilla Andrew-Nielsen, Head of Unit Clinical Trials & Licenses, Medical Products Agency (MPA)
Fast facts from “The Swedish Drug Discovery and Development Pipeline 2023”
Companies headquartered in Sweden are currently researching new medicines.
Pharmaceutical projects underway, more than 100 in the field of cancer
Of the pharmaceutical companies are from academia or health care sector
