SWOT analysis of decentralised clinical trials from an ethical, legal, regulatory and operational perspective

Abstract

Background: Decentralised clinical trial (DCT) approaches are characterised by moving operational procedures from the traditional on-site setting to the participant’s immediate surroundings through the use of digital tools. DCTs have received increased interest in recent years. In this article, a SWOT analysis was carried out to identify the strengths, weaknesses, opportunities, and threats for DCT approaches from an ethical, legal, regulatory and operational perspective, as compared to conventional clinical trials (CCTs). Methods: During a two-day workshop organised on 5 and 6 April 2022 at Utrecht University, a group of 10 experts from the IMI project Trials@Home identified 8 key trial activities (KTAs) which operational procedures differ between DCTs and CCTs and carried out a SWOT analysis for each activity separately: implementation of decentralised/remote (electronic) informed consent; decentralised screening of potential trial participants; home health visits; telemedicine visits; participant’s self-monitoring; delivery and return of investigational product; clinical trial oversight; and remote safety monitoring. These analyses were categorised to form an overall SWOT analysis for DCTs. Results: The analysis revealed 48 strengths, 62 weaknesses, 5 opportunities, and 13 threats across the eight KTAs. Categorisation distilled these into 11 strengths, 13 weaknesses, 2 opportunities, and 4 threats for DCTs. The use of digital technologies, lack of face-to-face contact and harmonisation of regulation were the most targeted issues. Conclusions: DCTs offer potential advantages, such as remote participation, greater autonomy in decision-making, simplified monitoring and access to diverse populations. However, challenges include digital technology barriers, reduced face-to-face contact, difficulties in identity verification and privacy issues. Addressing these challenges requires adequate training of participants and healthcare professionals, robust identity verification methods, strong security measures, and adaptation of communication and procedures. A hybrid approach combining traditional and decentralised elements seems feasible at this stage. Future research should explore the identified strengths and weaknesses of DCTs, propose ethical solutions to remaining challenges and ensure the inclusion of diverse stakeholders.