ReviewMedical sciences (Basel, Switzerland)2025
Decentralized Clinical Trials: Governance, Ethics and Medico-Legal Issues for the New Paradigm of Research with a Focus on Cardiovascular Field.
Review in Medical sciences (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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
2 citing papers in PubMed.
- Embracing Digital as a Paradigm Shift in Medical Affairs.Pharmaceutical medicine · 2026Review
- Ethical Challenges and Considerations in Decentralized Clinical Trials (DCTs): Insights from a Scoping Review.Therapeutic innovation & regulatory science · 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
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The evolution of decentralized clinical trials, driven by advanced digital technologies, is transforming traditional clinical research. It introduces innovative methods for informed consent, remote patient monitoring, and data analysis, enhancing study efficiency, validity, and participation while reducing patient burden. Some clinical procedures can be conducted remotely, increasing trial accessibility and reducing population selection biases, particularly for cardiovascular patients. However, this also presents complex regulatory and ethical challenges. The article explores how digital platforms and emerging technologies like block chain, AI, and advanced cryptography can promote traceability, security, and transparency throughout the trial process, ensuring participant identification and documentation of each procedural step. Clear, legally compliant informed consent, often managed through electronic systems, both for research participation and data management in line with GDPR, is essential. Ethical considerations include ensuring participants understand trial information, with adaptations such as simplified language, visual aids, and multilingual support. The transnational nature of decentralized trials highlights the need for coordinated regulatory standards to overcome jurisdictional barriers and reinforce accountability. This framework promotes trust, shared responsibility, and the protection of participants rights while upholding high ethical standards in scientific research.
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.