ArticleTherapeutic innovation & regulatory science2026
Ethical Challenges and Considerations in Decentralized Clinical Trials (DCTs): Insights from a Scoping Review.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
backgroundDecentralized clinical trials (DCTs) leverage digital health technologies to conduct trials outside traditional settings, offering numerous benefits such as increased participant diversity and breaking down geographic and transportation barriers. However, they also present significant ethical challenges. Current regulatory and ethical frameworks are not fully equipped to address these issues, highlighting a critical gap in effective governance and oversight of DCTs. This scoping review aims to systematically identify and synthesise the ethical challenges reported in the literature and to outline recommendations that can inform future guidance and practice.
methodsThis scoping review followed Arksey and O'Malley's framework. We searched PubMed, Web of Science, and SCOPUS for peer-reviewed articles in English and applied predefined inclusion and exclusion criteria to guide study selection.
resultsThe initial search yielded 757 documents. After applying inclusion and exclusion criteria and conducting a rigorous two-stage screening process, 32 articles were selected for detailed analysis. These articles identified six main areas of ethical challenges: electronic informed consent, equity and access, privacy and confidentiality, participant safety and welfare, scientific validity, and ethical and regulatory oversight.
conclusionsThis review underscores the necessity for clear guidelines, enhanced digital literacy, robust data protection measures, and comprehensive regulatory frameworks to address the ethical challenges of DCTs. By synthesizing existing literature, this paper provides actionable recommendations, such as simplifying consent processes and improving technical support, and identifies areas for future research to ensure DCTs are conducted ethically and effectively.
Indexed as
Identifiers
41806287What 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.