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

ABSTRACT: 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 2

SUBMITTER: de Jong AJ 

PROVIDER: S-EPMC12318156 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature