Lack of transparent reporting of trial monitoring approaches in randomised controlled trials: A systematic review of contemporary protocol papers
Open accessAbstract
Background: Monitoring is essential to ensure patient safety and data integrity in clinical trials as per Good Clinical Practice. The Standard Protocol Items: Recommendations for Interventional Trials Statement and its checklist guides authors to include monitoring in their protocols. We investigated how well monitoring was reported in published ‘protocol papers’ for contemporary randomised controlled trials. Methods: A systematic search was conducted in PubMed to identify eligible protocol papers published in selected journals between 1 January 2020 and 31 May 2020. Protocol papers were classified by whether they reported monitoring and, if so, by the details of monitoring. Data were summarised descriptively. Results: Of 811 protocol papers for randomised controlled trials, 386 (48%; 95% CI: 44%–51%) explicitly reported some monitoring information. Of these, 20% (77/386) reported monitoring information consistent with an on-site monitoring approach, and 39% (152/386) with central monitoring, 26% (101/386) with a mixed approach, while 14% (54/386) did not provide sufficient information to specify an approach. Only 8% (30/386) of randomised controlled trials reported complete details about all of scope, frequency and organisation of monitoring; frequency of monitoring was the least reported. However, 6% (25/386) of papers used the term ‘audit’ to describe ‘monitoring’. Discussion: Monitoring information was reported in only approximately half of the protocol papers. Suboptimal reporting of monitoring hinders the clinical community from having the full information on which to judge the validity of a trial and jeopardises the value of protocol papers and the credibility of the trial itself. Greater efforts are needed to promote the transparent reporting of monitoring to journal editors and authors.
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It is widely recommended that trials adopt a risk based approach to monitoring that focuses on the trial data and processes that are critical to study integrity, data validity, and the wellbeing of participants.
“Rather than reviewing 100% of accumulating data and processes, it is widely recommended that trials adopt a risk based approach to monitoring that focuses on the trial data and processes that are critical to study integrity, data validity, and the wellbeing of participants.46 467”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [467]
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- Authors
- Hsieh, S.-F., Yorke-Edwards, V., Murray, M. L., Diaz-Montana, C., Love, S. B., & Sydes, M. R.
- Affiliations
- MRC Clinical Trials Unit at UCL (GB)
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK
- Corresponding author
- Yorke-Edwards, Victoria
- ORCID
- Venue
- Clinical Trials
- Publisher
- SAGE Publications
- Published
- 2023-01-11
- Volume
- 20
- Issue
- 2
- Pages
- 121-132
- ISSN
- 1740-7745 (ISSN-L)
- 1740-7753
- PMC
- PMC10021127
- OpenAlex
- W4315569134
- Cited by
- 5
- References
- 23
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 2 · 2023: 1
- FWCI
- 0.35
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Clinical Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion, cc-by)
- Funders
- Health Data Research UK
- Medical Research Council (MC_UU_12023/24)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Keywords
- clinical trial monitoring, randomized controlled trials, reporting transparency, central monitoring, field monitoring, monitoring frequency, auditing, alcoholic beverages, good clinical practice, patient safety, data integrity
- MeSH terms
- Systematic Reviews as Topic, Humans, Research Design, Randomized Controlled Trials as Topic, Checklist
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