Ethics review or compliance check? an empirical analysis of 6740 requests for information in Belgian clinical trial evaluations (2017-2024).

ABSTRACT: The EU Clinical Trials Regulation (CTR) was introduced to harmonize clinical trial evaluations across Member States while upholding participant protection and ethical integrity. This study analyzes 6740 Requests for Information (RFIs) issued by Belgian Medical Research Ethics Committees (MRECs) across 266 trial dossiers evaluated between 2017 and 2024, spanning both the CTR pilot phase and the initial CTIS implementation. Using framework content analysis, we examined the number and content of RFIs in relation to trial outcomes, sponsor type (commercial vs. non-commercial), and the MREC's role as Reporting Member State (RMS) or Member State Concerned (MSC).Results show a decline in total RFIs over time, mainly due to a reduction in typographical and linguistic remarks, yet significant varia

SUBMITTER: Van Scharen A 

PROVIDER: S-EPMC12506313 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature