On March 16, Peter Asplund’s report on clinical trials in Sweden was presented, containing proposals that should contribute to a long-term competitive and sustainable environment for clinical trials – with a special focus on company-initiated clinical trials in Sweden.
SwedenBIO’s task force on clinical trials comments on the investigation through Maja Neiman, Science Relations Manager:
“Our most important comment is that the investigation is very well done, impressively anchored and very welcome! Now we want to see that the concrete proposals that this investigation puts forward are also implemented.”
The downward trend for clinical drug trials in Sweden has continued during 2013-2022, apart from an increase in 2021, which is likely a pandemic effect. During the period, the number of company-initiated clinical trials has decreased by 22 percent.”
The investigation, led by Peter Asplund, operations manager in Region Örebro, has analyzed the reasons why Sweden today carries out fewer clinical drug trials and the efforts that were previously made to reverse the trend, and also made comparisons with other comparable countries. The investigation states in their report Proposals for measures to create better conditions for clinical trials – for better welfare and a stronger life science sector that the downward trend for clinical drug trials in Sweden has continued during 2013-2022, apart from an increase in 2021, which is likely a pandemic effect. During the period, the number of company-initiated clinical trials has decreased by 22 percent.
The most important proposal in the investigation is the establishment of a national cross-sector partnership for collaboration, called SweTrial, which can take the lead and drive these issues forward, according to SwedenBIO. “A clear, central and overall responsibility and leadership is needed to bring everyone involved together to move forward,” they state.
The Ministry of Social Affairs is proposed to bring together representatives of the life science sector and the six healthcare regions in the partnership. The partnership should be financed by the state and the authorities Vinnova and the National Board of Health and Welfare are also proposed to contribute with strategic development, follow-up and evaluation.
Lif Sweden also takes a very positive view of the proposals in the investigation. SweTrial is fully in line with proposals presented by the Swedish pharmaceutical industry association in its action plan for clinical trials to bring together actors involved in clinical drug trials at national level to take joint responsibility.
We also interpret it as an ambition-driven partnership where those who want to be involved and drive the work are welcome to participate.”
“We also interpret it as an ambition-driven partnership where those who want to be involved and drive the work are welcome to participate. It is a success factor that will contribute to moving the positions forward. We are extra happy about the proposal that Lif should be part of the steering group and represent the researching pharmaceutical companies,” states Frida Lundmark, Policy expert at Lif Sweden.
The existing clinical trial units that meet SweTrial’s minimum criteria should be able to apply for funds to develop their operations, especially with regard to company-initiated clinical trials.”
The investigation points to a lack of delivery capacity as one of the problem areas and proposes financial incentives. The existing clinical trial units that meet SweTrial’s minimum criteria should be able to apply for funds to develop their operations, especially with regard to company-initiated clinical trials, explains Lif Sweden. The grant will, for example, go towards expanding the workforce.
Frida Lundmark also welcomes the proposal that the Ethics Review Authority should be given an expanded mission to produce statistics on lead times for clinical trials and the number of participants. “You must be able to follow up and report back to get an overview of how the conditions develop with the new investments,” she states.
Biobanks and laws
Another proposal concerns a new role for Kliniska Studier Sverige. According to the investigation, the investment with its nodes has been significant for academic research, but has not constituted a support system in a corresponding way for company-initiated trials. The investigation now proposes that Kliniska Studier Sverige should focus only on academic research.
The investigation also wants to see government financial support for regional biobank centers and for Biobank Sweden. Another proposal concerns a number of laws that continue to be obstacles to clinical trials. The investigation lists a number of laws that directly or indirectly hinder clinical trials and suggests that the government investigate these further with the aim of removing the obstacles.
Photo of Maja Neiman, SwedenBIO (left): Camille Sonally
Photo of Frida Lundmark, Lif Sweden (right): Gunilla Lundström