Experiences with low-intervention clinical trials—the new category under the European Union Clinical Trials Regulation

Background/AimsLow-intervention clinical trials have been established under the European Union Clinical Trials Regulation (EU 536/2014) which aims to simplify the conduct of clinical trials with authorized medicinal products. There is limited experience with conducting low-intervention trials. Therefore, this study aims to report on experiences and perceived (dis)advantages of low-intervention trials.MethodsWe surveyed representatives of all individual clinical trials registered on the public website of the European Union Clinical Trials Information System between 31 January 2022 and 1 December 2023 that evaluated authorized investigational medicinal products and had at least one investigative site in the European Union. These representatives were approached between June 2023 and January 2024.ResultsWe received 70 responses (response rate 21%). Of the respondents, 31 represented a trial registered as low-intervention trial, and 39 represented a trial not registered as a low-intervention trial (hereafter "regular trials"). Simplified clinical trial monitoring and an easier regulatory approval process were perceived as the main advantages of low-intervention trials, with respectively 44% and 34% of the respondents indicating this to be an advantage in low-intervention trials. However, the respondents experienced that stringent and unclear regulatory requirements impeded the conduct of low-intervention trials. Respondents involved with regular trials indicated that 39% of the regular trials met the criteria of a low-intervention trial but were not registered as such, among others due to unfamiliarity with this trial category.ConclusionsWe argue that the simplified procedures for low-intervention trials should be more detailed-for example in regulatory guidance-in the future to further simplify the conduct of clinical trials with authorized investigational medicinal products.