ArticleBMJ open2022
Which decentralised trial activities are reported in clinical trial protocols of drug trials initiated in 2019-2020? A cross-sectional study in ClinicalTrials.gov.
Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
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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
16 citing papers in PubMed, 20 citations in OpenAlex.
- Article
- Decentralized clinical trials: A comprehensive analysis of trends, technologies, and global challenges.PLOS digital health · 2026Article
- Trial characteristics, methods and reported challenges of decentralised clinical trials: a scoping review.BMJ open · 2025Article
- Bringing Trial Activities to Participants-The Trials@Home RADIAL Proof-of-Concept Trial Investigating Decentralization of Trials.Clinical pharmacology and therapeutics · 2025Article
- The Supply of Investigational Medicinal Product and Management of Study Materials for Decentralized Participants-Insights from the Trials@Home RADIAL Proof-of-Concept Trial.Clinical pharmacology and therapeutics · 2025Article
- Regulatory Interactions and Learnings-RADIAL the Trials@Home Proof-of-Concept Trial on Decentralization.Clinical pharmacology and therapeutics · 2025Article
- Adaptation of Clinical Research Staff to Decentralized Clinical Trials and Impacts on the Patient-Centered Experience: Qualitative Interview Study.Journal of medical Internet research · 2025Article
- Diversity in decentralized clinical trials: prioritizing inclusion of underrepresented groups.BMC medical ethics · 2025Review
- Exploration of Using an Open-Source Large Language Model for Analyzing Trial Information: A Case Study of Clinical Trials With Decentralized Elements.Clinical and translational science · 2025Article
- Study on knowledge, practices, and attitudes toward decentralized clinical trials among the clinical trial practitioners in China.Frontiers in medicine · 2025Article
- Narrative review of telemedicine applications in decentralized research.Journal of clinical and translational science · 2024Review
- Article
- Despite negative perceptions of clinical trial conduct during the coronavirus disease 2019 (COVID-19) pandemic, are decentralized clinical trial methods here to stay?Annals of translational medicine · 2023Article
- Reimagining the joint task force core competency framework for rural and frontier clinical research professionals conducting hybrid and decentralized trials.Frontiers in pharmacology · 2023Article
- Article
- Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle?Digital healthArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesDecentralised clinical trial activities-such as participant recruitment via social media, data collection through wearables and direct-to-participant investigational medicinal product (IMP) supply-have the potential to change the way clinical trials (CTs) are conducted and with that to reduce the participation burden and improve generalisability. In this study, we investigated the decentralised and on-site conduct of trial activities as reported in CT protocols with a trial start date in 2019 or 2020.
designWe ascertained the decentralised and on-site conduct for the following operational trial activities: participant outreach, prescreening, screening, obtaining informed consent, asynchronous communication, participant training, IMP supply, IMP adherence monitoring, CT monitoring, staff training and data collection. Results were compared for the public versus private sponsors, regions involved, trial phases and four time periods (the first and second half of 2019 and 2020, respectively).
settingPhases 2, 3 and 4 clinical drug trial protocols with a trial start date in 2019 or 2020 available from ClinicalTrials.gov. OUTCOME MEASURES: The occurrence of decentralised and on-site conduct of the predefined trial activities reported in CT protocols.
resultsFor all trial activities, on-site conduct was more frequently reported than decentralised conduct. Decentralised conduct of the individual trial activities was reported in less than 25.6% of the 254 included protocols, except for decentralised data collection, which was reported in 68.9% of the protocols. More specifically, 81.9% of the phase 3 protocols reported decentralised data collection, compared with 73.3% and 47.0% of the phase 2 and 4 protocols, respectively. For several activities, including prescreening, screening and consenting, upward trends in reporting decentralised conduct were visible over time.
conclusionsDecentralised methods are used in CTs, mainly for data collection, but less frequently for other activities. Sharing best practices and a detailed description in protocols can drive the adoption of decentralised methods.
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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.