ArticleJournal of clinical and translational science2020
The role of data and safety monitoring boards in implementation trials: When are they justified?
Article in Journal of clinical and translational science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 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
12 citing papers in PubMed.
- Trial
- Ethical considerations in implementation research: a scoping review of key principles, unintended consequences, and emerging ethical guidance.Implementation science communications · 2025Review
- Implementation strategies to integrate HIV and hypertension care in Kampala and Wakiso districts, Uganda: study protocol for a stepped wedge cluster randomized trial (PULESA-Uganda).BMC health services research · 2025Article
- Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory.Contemporary clinical trials · 2025Article
- Conceptualizing patient-level adverse effects in implementation trials.Annals of epidemiology · 2025Article
- Community partners identified implementation considerations prior to a randomized clinical trial for uncontrolled asthma in Federally Qualified Health Centers.Journal of clinical and translational science · 2025Article
- Ethical issues in implementation science: perspectives from a National Heart, Lung, and Blood Institute workshop.Implementation science : IS · 2024Article
- A pragmatic, stepped-wedge, hybrid type II trial of interoperable clinical decision support to improve venous thromboembolism prophylaxis for patients with traumatic brain injury.Implementation science : IS · 2024Article
- Do no harm: the impact of implementing cancer prevention strategies on other preventive health measures.Implementation science communications · 2024Article
- Guidelines for Data and Safety Monitoring in Pragmatic Randomized Clinical Trials Using Case Studies.Mayo Clinic proceedings · 2023Review
- Maternal Perceptions of Safeguards for Research Involving Children.Journal of child and family studies · 2022Article
- Introduction to theJournal of clinical and translational science · 2020Article
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
Abstract
The National Institutes of Health requires data and safety monitoring boards (DSMBs) for all phase III clinical trials. The National Heart, Lung and Blood Institute requires DSMBs for all clinical trials involving more than one site and those involving cooperative agreements and contracts. These policies have resulted in the establishment of DSMBs for many implementation trials, with little consideration regarding the appropriateness of DSMBs and/or key adaptations needed by DSMBs to monitor data quality and participant safety. In this perspective, we review the unique features of implementation trials and reflect on key questions regarding the justification for DSMBs and their potential role and monitoring targets within implementation 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.