Swedish Government Launches Initiative to Boost Clinical Trials Participation

The Swedish government has initiated an investigation under the leadership of Healthcare Minister Acko Ankarberg Johansson to increase the number of clinical trials conducted in Sweden. Highlighting the pivotal role of clinical trials in facilitating medical breakthroughs and ensuring patients have timely access to new treatments, Johansson stated that regulatory reforms are necessary to simplify procedures and reduce barriers for companies interested in conducting trials in the country.

The investigation will analyze the involvement of vulnerable groups in clinical trials, specifically focusing on individuals with impaired decision-making capacity, such as those with dementia. It seeks to address current regulatory limitations that hamper research in emergency situations, including periods when patients may be unconscious or in intensive care. A consideration of allowing cluster-randomized trials—where treatment is administered to entire groups like hospital units—will also be made to streamline the conduct of larger, more effective studies, a method which gained traction during the pandemic.

Furthermore, the investigation plans to re-evaluate the language requirements for clinical trial applications, as Sweden's current standards are more stringent than those of many EU countries, which may deter international cooperation and investment. Johan Borgström has been appointed as the special investigator for this crucial project, and a report is expected to be submitted by June 15, 2026, outlining potential adjustments while safeguarding patient safety.