ArticleTrials2019
Principles and procedures for data and safety monitoring in pragmatic clinical trials.
Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 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
19 citing papers in PubMed.
- Optimising data completeness and quality in multicentre randomised clinical trials using central data monitoring: a pragmatic approach.BMC medical research methodology · 2026Trial
- Patient monitoring in a pragmatic, multicenter trial of incremental hemodialysis: early experience from the TwoPlus randomized controlled trial.BMC nephrology · 2025Trial
- Evaluating the Safety of an Educational Deprescribing Intervention: Lessons from the Optimize Trial.Drugs & aging · 2024Trial
- Trial
- A Pragmatic Clinical Trial Approach to Assessing and Monitoring Suicidal Ideation: Results from A National US Trauma Care System Study.Psychiatry · 2022Trial
- Central data monitoring in the multicentre randomised SafeBoosC-III trial - a pragmatic approach.BMC medical research methodology · 2021Trial
- Empirical research related to the ethics of pragmatic clinical trials: A scoping review.Learning health systems · 2026Article
- Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory.Contemporary clinical trials · 2025Article
- Ethical considerations for sharing aggregate results from pragmatic clinical trials.Clinical trials (London, England) · 2025Article
- Pragmatic Clinical Decision Support Trial of Pre-checked Default Orders: Monitoring Safety and Adverse Clinical Outcomes.Journal of general internal medicine · 2025Article
- Monitoring and reporting adverse events in pragmatic clinical trials testing nonpharmacological pain management interventions.Pain medicine (Malden, Mass.) · 2024Article
- Article
- Navigating the challenges of clinical trial professionals in the healthcare sector.Frontiers in medicine · 2024Review
- Guidelines for Data and Safety Monitoring in Pragmatic Randomized Clinical Trials Using Case Studies.Mayo Clinic proceedings · 2023Review
- Comparing the Safety Action Feedback and Engagement (SAFE) Loop with an established incident reporting system: Study protocol for a pragmatic cluster randomized controlled trial.Contemporary clinical trials communications · 2023Article
- The evolving role of data & safety monitoring boards for real-world clinical trials.Journal of clinical and translational science · 2023Article
- Stakeholder perspectives regarding pragmatic clinical trial collateral findings.Learning health systems · 2021Article
- Designing and undertaking randomised implementation trials: guide for researchers.BMJ (Clinical research ed.) · 2021Article
- The role of data and safety monitoring boards in implementation trials: When are they justified?Journal 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
6 authors.
Funding
Abstract
backgroundAll clinical trial investigators have ethical and regulatory obligations to monitor participant safety and trial integrity. Specific procedures for meeting these obligations, however, may differ substantially between pragmatic trials and traditional explanatory clinical trials. METHODS/
resultsAppropriate monitoring of clinical trials typically includes assessing rate of recruitment or enrollment; monitoring safe and effective delivery of study treatments; assuring that study staff act to minimize risks; monitoring quality and timeliness of study data; and considering interim analyses for early detection of benefit, harm, or futility. Each of these responsibilities applies to pragmatic clinical trials. Just as design of pragmatic trials typically involves specific and necessary departures from methods of explanatory clinical trials, appropriate monitoring of pragmatic trials typically requires specific departures from monitoring procedures used in explanatory clinical trials. We discuss how specific aspects of pragmatic trial design and operations influence selection of monitoring procedures and illustrate those choices using examples from three ongoing pragmatic trials conducted by the Mental Health Research Network.
conclusionsPragmatic trial investigators should not routinely adopt monitoring procedures used in explanatory clinical trials. Instead, investigators should consider core principles of trial monitoring and design monitoring procedures appropriate for each pragmatic trial.
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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.