ArticleTrials2014
Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit.
Article in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.
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
11 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Monitoring strategies for clinical intervention studies.The Cochrane database of systematic reviews · 2021Pooled it
- Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics.Trials · 2018Pooled it
- Abstract Versus Concrete Risk Identification in Clinical Research in Japan: Randomized and Prospective Pilot Research on the Effect of Risk Reduction Activities in a Risk-Based Approach.Therapeutic innovation & regulatory science · 2025Trial
- Trial
- Review
- Measuring What Matters in Trial Operations: Development and Validation of the Clinical Trial Site Performance Measure.Journal of clinical medicine · 2025Article
- Developing a quality indicator system for pediatric clinical trials management of research centers in China: a modified Delphi-Analytic Hierarchy Process study.BMC pediatrics · 2025Article
- Navigating investigator-initiated clinical trials: A call for guidelines & monitoring frameworks from an Indian context.The Indian journal of medical research · 2024Review
- Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: A scoping review.Clinical trials (London, England) · 2021Article
- Article
- Generating evidence on a risk-based monitoring approach in the academic setting - lessons learned.BMC medical research methodology · 2017Article
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
backgroundSome level of monitoring is usually required during a clinical trial to protect the rights and safety of trial participants and to safeguard the quality and reliability of trial results. Although there is increasing support for the use of risk-proportionate approaches to achieve these aims, the variety of methods and lack of an empirical evidence base can present challenges for clinical trial practitioners.
methodsThis paper describes the monitoring methods and procedures that are utilised by a non-commercial clinical trials unit which coordinates a range of clinical trials across a variety of clinical areas with different associated risks.
resultsMonitoring activities and approaches should be selected to be proportionate to the risks identified within a trial. A risk-proportionate approach to monitoring is described giving details of methods that may be considered by clinical trial practitioners during the development of a trial monitoring plan. An example risk assessment and corresponding monitoring plan for a low risk (type A in the Medicines and Healthcare Products Regulatory Agency (MHRA) classification system) pediatric trial is provided for illustration.
conclusionWe present ideas for developing a monitoring plan for a clinical trial of an investigational medicinal product based on our experience. Alternative approaches may be relevant or preferable in other settings based on inherent risk.
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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.