TY - JOUR
T1 - Experiences with low-intervention clinical trials-the new category under the European Union Clinical Trials Regulation
AU - de Jong, Amos J
AU - Gardarsdottir, Helga
AU - Santa-Ana-Tellez, Yared
AU - de Boer, Anthonius
AU - Zuidgeest, Mira Gp
N1 - Publisher Copyright:
© The Author(s) 2025. This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
PY - 2025/8
Y1 - 2025/8
N2 - BACKGROUND/AIMS: Low-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.METHODS: We 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.RESULTS: We 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.CONCLUSIONS: We 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.
AB - BACKGROUND/AIMS: Low-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.METHODS: We 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.RESULTS: We 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.CONCLUSIONS: We 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.
KW - European Clinical Trials regulation
KW - investigator-initiated trials
KW - low-intervention clinical trials
KW - pragmatic trials
KW - regulatory science
KW - risk-based approach
UR - https://www.scopus.com/pages/publications/85216570308
U2 - 10.1177/17407745241309293
DO - 10.1177/17407745241309293
M3 - Article
C2 - 39844438
SN - 1740-7745
VL - 22
SP - 494
EP - 500
JO - Clinical Trials
JF - Clinical Trials
IS - 4
M1 - doi.org/10.1177/17407745241309293
ER -