A comprehensive analysis of European clinical trial governance: The evolution from directive to regulation

Abstract

The implementation of the new European Clinical Trial Regulation on January 31, 2022, marks a significant advancement in promoting clinical research across Europe. This article comprises three key sections aimed at elucidating the transition from the previous clinical trial directives to the new regulation and its implications. The introductory segment provides a simplified overview of the historical context and limitations of clinical trial directives, setting the stage for a deeper exploration of the subsequent clinical trial regulation-related information. Here, the basic work structure of the Clinical Trial Information System (CTIS) is outlined alongside the transition period from directives to regulation, highlighting key differences between the two. Additionally, various differentiators of the regulation are highlighted, including coordinated assessments, increased public transparency, new definitions such as “low intervention clinical trials,” stricter timelines, simplified safety reporting, and improved patient protections. Lastly, the article creatively explores the guidance document titled “Guidance for the Transition of Clinical Trials from the Clinical Trial Directive to Clinical Trial Regulation,” elucidating its contents in an easy-to-understand manner. In summary, this article offers a concise yet comprehensive overview of the clinical trial directive, clinical trial regulation, and the clinical trial information system, while highlighting key differentiators of the regulation and the transition process, guided by the directive-to-regulation transition document.