ArticleBMC medical ethics2026
SWOT analysis of decentralised clinical trials from an ethical, legal, regulatory and operational perspective.
Article in BMC medical ethics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Addressing the Key Challenges of Decentralized Clinical Trials in Europe: Multistakeholder Perspective Delphi Study.Journal of medical Internet research · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundDecentralised 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).
methodsDuring 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.
resultsThe 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.
conclusionsDCTs 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.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.