Understanding the Experiences and Needs of Participants in Decentralised Clinical Trials: A Qualitative Analysis

Abstract Background Experts across industry, academia, and regulatory bodies increasingly stress the importance of prioritising participant experiences in clinical trials. Simultaneously, the shift towards decentralised approaches is reshaping how trials are designed and conducted, with a direct impact on the experiences of the participants involved. Objective This study aims to gain a deeper understanding of the experiences of participants taking part in Decentralised Clinical Trials, focusing on the unique challenges and opportunities presented by remote trial participation, and the tools and organisational processes that support participation. Methods This exploratory qualitative study involved interviews with fourteen individuals who had personal experience participating in remote or decentralised clinical trials. The interview transcripts were analysed using reflexive thematic analysis to identify key patterns and insights. Results We generated six main themes: (1) Positive experiences with remote participation, (2) co-ownership and meaningful engagement, (3) increasingly fragmented care and support, (4) confusion and uncertainty in navigating the trial, (5) need for human interaction and connection, (6) the hidden workload - navigating the burdens of remote trial participation. While the remote trial is an adaptable and sustainable model offering several benefits for participants and potential for clinical trials, it introduces complexities and challenges for participants that can negatively impact engagement and experience. Conclusion This study recognises both the potential benefits and challenges introduced by remote trial participation. It underscores the need for technology that not only streamlines trial processes but also responds to the needs, experiences, and well-being of participants. This requires rethinking trial technology features and functionality, strengthening collaboration with stakeholders, and focusing on elements of the participant experience that go beyond remote access and rudimentary data collection.