ReviewInternational journal of clinical oncology2020
Central statistical monitoring of investigator-led clinical trials in oncology.
Review in International journal of clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Monitoring strategies for clinical intervention studies.The Cochrane database of systematic reviews · 2021Pooled it
- Flexible outlier detection in multicenter clinical trials.Journal of clinical and translational science · 2026Article
- Central statistical monitoring in clinical trial management: A scoping review.Clinical trials (London, England) · 2025Article
- Determining the extent and frequency of on-site monitoring: a bayesian risk-based approach.BMC medical research methodology · 2024Article
- Application of Statistical Methods for Central Statistical Monitoring and Implementations on the German Multiple Sclerosis Registry.Therapeutic innovation & regulatory science · 2023Article
- Performance of four centralized statistical monitoring methods for early detection of an atypical center in a multicenter study.Contemporary clinical trials communications · 2023Article
- Infectious diseases epidemiology, quantitative methodology, and clinical research in the midst of the COVID-19 pandemic: Perspective from a European country.Contemporary clinical trials · 2020Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Investigator-led clinical trials are pragmatic trials that aim to investigate the benefits and harms of treatments in routine clinical practice. These much-needed trials represent the majority of all trials currently conducted. They are however threatened by the rising costs of clinical research, which are in part due to extensive trial monitoring processes that focus on unimportant details. Risk-based quality management focuses, instead, on "things that really matter". We discuss the role of central statistical monitoring as part of risk-based quality management. We describe the principles of central statistical monitoring, provide examples of its use, and argue that it could help drive down the cost of randomized clinical trials, especially investigator-led trials, whilst improving their quality.
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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.