Yorke-Edwards, Victoria;
Hsieh, Shao-Fan;
Murray, Macey L;
Diaz-Montana, Carlos;
Love, Sharon B;
Sydes, Matthew R;
(2022)
P203: Lack of transparent reporting of trial monitoring approaches in randomised controlled trials: a systematic review of contemporary protocol papers.
Presented at: International Clinical Trials Methodology Conference 2022, Harrogate, UK.
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Abstract
Background: Monitoring is essential to ensure patient safety and data integrity in clinical trials as per Good Clinical Practice. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist guides authors to include monitoring in their protocols. We investigated the reporting prevalence and detail of monitoring in published “protocol papers” for contemporary randomised controlled trials (RCTs). Methods: A systematic search was conducted in PubMed to identify eligible protocol papers published in key journals. Articles were further classified by whether they reported monitoring. Descriptive data were summarised for the reporting prevalence of monitoring and the reporting extent. / Results: Of 811 protocol papers, 386 RCTs (48%; 95% CI: 44% to 51%) explicitly reported monitoring information. In particular, 20% (77/386) of RCTs reporting monitoring information described an approach consistent with on-site monitoring, 39% (152/386) with central monitoring, 26% (101/386) with a mixed approach, whilst 14% (54/386) did not provide sufficient information to specify an approach. Only 8% (30/386) of RCTs reported complete details about scope, frequency and organisation, and the monitoring frequency was the least reported. Moreover, 6% (25/386) of protocol papers interchangeably used “audit” to describe “monitoring”. / Discussion: Monitoring information was only reported in half of the published protocols. Suboptimal reporting of monitoring, as shown in this study, hinders the clinical community from having the full information on which to judge the validity of a trial externally and jeopardises the value of protocol papers and trial credibility. Greater efforts are needed to promote the transparent reporting of monitoring to journal editors and authors.
| Type: | Poster |
|---|---|
| Title: | P203: Lack of transparent reporting of trial monitoring approaches in randomised controlled trials: a systematic review of contemporary protocol papers |
| Event: | International Clinical Trials Methodology Conference 2022 |
| Location: | Harrogate, UK |
| Dates: | 03 - 06 October 2022 |
| Open access status: | An open access version is available from UCL Discovery |
| Publisher version: | https://doi.org/10.5281/zenodo.7741866 |
| Language: | English |
| UCL classification: | UCL |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10196401 |
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