Navigating the future of clinical trial management – insights on the transformative role of AI

Abstract

This study addresses the current lack of empirical data on the experiences and attitudes of clinical research professionals towards AI-powered clinical trial management tools. Clinical research professionals affiliated with various Swiss and international clinical research networks were invited to participate in an online survey. The survey focused on nine use cases of AI-powered clinical trial management tools. Participants were asked to share their ethical considerations, and their experiences were assessed at both the individual and institutional levels. Answers from 110 participants, primarily from Swiss academic institutions, were included in the data analysis. While participants generally held positive attitudes, mixed views were also common. Governmental attitudes were widely perceived as unclear or cautious, with the associated regulatory opacity possibly contributing to the limited adoption of AI in trial management observed in this study. In addition to a clear AI governance, ethical compliance and training emerged as crucial aspects. There was also broad consensus on the necessity of informing patients about tools’ uses and of ensuring an independent certification of the respective tools. The widespread adoption of AI-powered clinical trial management tools remains distant, entangled in a net of complexities that require further empirical investigation. Ethical concerns appear to play a crucial role, driven by distrust and the absence of a clear regulatory framework. Urgent actions are needed at both institutional and governmental levels, including the establishment of a governance framework and training provision.