Clinical studies during the pandemic – better coordination and more time for research are needed

A new report provides a concluding account of the Government’s mandate to the Swedish Research Council in April 2020, to temporarily strengthen the activities within Clinical Studies Sweden. The mandate included analysing Sweden’s capacity to implement clinical studies in crisis situations and at short notice, aimed at improving the care of patients with disease.

The analysis shows, among other things, that it has been difficult to coordinate research and to prioritise research issues during the ongoing pandemic, both within and between regions. It also shows that research-promoting infrastructure needs to be in place and be well-established if urgent research is to be carried out at short notice.

“What we are seeing is that the procedures and collaborations that work under normal circumstances are also working well during the pandemic. On the other hand, things that were lacking already before the pandemic have been difficult to create at short notice,” says Madeleine Durbeej-Hjalt, Secretary General for Medicine and Health at the Swedish Research Council.

The Swedish Research Council therefore considers that measures should focus on building up a well-functioning system for clinical studies in general, supplemented with specific functions that are needed in crisis situations.

The report also contains statistics for the COVID-19-related clinical studies approved by the Swedish Ethical Review Authority during the pandemic. This includes information about geographic distribution and expected project times for the research planned.

The Swedish Research Council’s eight recommendations

• Create financial incentives and establish a national agreement between government and healthcare principals to promote infrastructure, competence provision and national coordination within clinical research.
• Increase the Swedish Research Council’s resources for national coordination within Clinical Studies Sweden, aimed at strengthening collaboration between regions and developing and implementing more support tools and processes.
• Increase the support for building up research capacity, increasing research competence and building research networks and infrastructure in primary care.
• Ensure that clinically active personnel have more time set aside for research.
• Task the Swedish Ethical Review Authority and the Swedish Medical Products Agency to contribute to national statistics by making available data from their areas of activity.
• Ensure that the regions follow up studies to enable national summaries of ongoing and concluded studies.
• Task the Swedish Agency for Health Technology Assessment and Assessment of Social Services in a crisis situation to provide ongoing quality assurance of and summarise scientific literature in the topical area.
• Task the Life Science Office to develop processes that enables it in a crisis situation to rapidly establish a scientific council responsible for coordinating research initiatives and prioritising clinical studies nationally.