ReviewThe Lancet. Digital health2023
Decentralised clinical trials: ethical opportunities and challenges.
Review in The Lancet. Digital health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 1 of them a synthesis that pooled it.
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
50 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Recommendations to promote equity, diversity and inclusion in decentralized clinical trials.Nature medicine · 2024Guideline
- Trial
- Stakeholder-reported perspectives on decentralized clinical trials: A multi-country descriptive survey.Contemporary clinical trials communications · 2026Article
- Current Landscape of Investigator-Initiated Decentralized Clinical Trials in Japan: A Nationwide Survey.Therapeutic innovation & regulatory science · 2026Article
- Article
- The Future is Local: the Role of Decentralised Clinical Trials in Patients with Advanced Cancer Receiving Palliative Care.Current treatment options in oncology · 2026Review
- Addressing the Key Challenges of Decentralized Clinical Trials in Europe: Multistakeholder Perspective Delphi Study.Journal of medical Internet research · 2026Article
- A Multiregional Decentralized Clinical Trial Program to Improve Access.JAMA network open · 2026Article
- Who gets included? Equity in digital and decentralised mental health and neurodevelopmental trials: A systematic review.PLOS digital health · 2026Article
- Attitudes and Willingness to Participate in Drug Clinical Trials Among Patients With Cancer: Multistage Qualitative Study.Journal of medical Internet research · 2026Article
- Ethical Challenges and Considerations in Decentralized Clinical Trials (DCTs): Insights from a Scoping Review.Therapeutic innovation & regulatory science · 2026Article
- The next phase in Long COVID research: addressing the ethical challenges in trials of disease-modifying treatments.EClinicalMedicine · 2026Review
- Positioning Community Pharmacies in Nigeria as a Clinical Trial Partner: A Forward Perspective.Clinical and translational science · 2026Article
- Review
- SWOT analysis of decentralised clinical trials from an ethical, legal, regulatory and operational perspective.BMC medical ethics · 2026Article
- PAtient-Centric epilepsy clinical trIal model For Improved health outcomes using Cannabidiol (PACIFIC study)-a methodology for developing patient-centred clinical trials in rare epilepsy syndromes.BMC medical research methodology · 2026Article
- Decentralized clinical trials: A comprehensive analysis of trends, technologies, and global challenges.PLOS digital health · 2026Article
- Optimising clinical trial methods for complex regional pain syndrome: a methodological framework (OptiMeth-CRPS).Pain reports · 2025Article
- Article
- Trial characteristics, methods and reported challenges of decentralised clinical trials: a scoping review.BMJ open · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Fuelled by adaptations to clinical trial implementation during the COVID-19 pandemic, decentralised clinical trials are burgeoning. Decentralised clinical trials involve many digital tools to facilitate research without physical contact between research teams and participants at various stages, such as recruitment, enrolment, informed consent, administering study interventions, obtaining patient-reported outcome measures, and safety monitoring. These tools can provide ways of ensuring participants' safety and research integrity, while sometimes reducing participant burden and trial cost. Research sponsors and investigators are interested in expanding the use of decentralised clinical trials. The US Food and Drug Administration and other regulators worldwide have issued guidance on how to implement such adaptations. However, there has been little focus on the distinct ethical challenges these trials pose. In this Health Policy report, which is informed by both traditional research ethics and digital ethics frameworks, we group the related ethical issues under three areas requiring increased ethical vigilance: participants' safety and rights, scientific validity, and ethics oversight. Our aim is to describe these issues, offer practical means of addressing them, and prompt the delineation of ethical standards for decentralised trials.
Indexed as
Identifiers
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.