ArticleCureus2026
Data and Safety Monitoring Board Best Practices in Clinical Trials.
Article in Cureus, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
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
A Data and Safety Monitoring Board (DSMB), also referred to as a Data Monitoring Committee (DMC), plays a critical role in safeguarding participant safety and ensuring the integrity of clinical trials. This article provides a narrative overview of best practices in DSMB structure, governance, and operations, informed by regulatory guidance from the U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), European Medicines Agency (EMA), and selected literature, as well as practical experience in clinical trial oversight. Key domains addressed include DSMB composition and independence, charter development and governance, data access and integrity, safety monitoring processes, interim analyses and adaptive decision-making, confidentiality, and sponsor responsibilities. The article also discusses common operational challenges and mitigation strategies, along with emerging trends such as Bayesian monitoring approaches and decentralized trial oversight. Rather than prescribing specific statistical thresholds, the manuscript emphasizes principles for maintaining scientific rigor, ethical oversight, and regulatory alignment. This overview is intended to support sponsors, Clinical Research Organizations (CROs), and DSMB members in implementing effective and compliant safety monitoring practices across a range of clinical trial settings.
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.