Article ; Online: Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials.
Therapeutic innovation & regulatory science
2024 Volume 58, Issue 3, Page(s) 483–494
Abstract: Background: Central monitoring aims at improving the quality of clinical research by pro-actively identifying risks and remediating emerging issues in the conduct of a clinical trial that may have an adverse impact on patient safety and/or the ... ...
| Abstract | Background: Central monitoring aims at improving the quality of clinical research by pro-actively identifying risks and remediating emerging issues in the conduct of a clinical trial that may have an adverse impact on patient safety and/or the reliability of trial results. This paper, focusing on statistical data monitoring (SDM), is the second of a series that attempts to quantify the impact of central monitoring in clinical trials. Material and methods: Quality improvement was assessed in studies using SDM from a single large central monitoring platform. The analysis focused on a total of 1111 sites that were identified as at-risk by the SDM tests and for which the study teams conducted a follow-up investigation. These sites were taken from 159 studies conducted by 23 different clinical development organizations (including both sponsor companies and contract research organizations). Two quality improvement metrics were assessed for each selected site, one based on a site data inconsistency score (DIS, overall -log Results: The SDM quality metrics showed improvement in 83% (95% CI, 80-85%) of the sites across therapeutic areas and study phases (primarily phases 2 and 3). In contrast, only 56% (95% CI, 41-70%) of sites showed improvement in 2 historical studies that did not use SDM during study conduct. Conclusion: The results of this analysis provide clear quantitative evidence supporting the hypothesis that the use of SDM in central monitoring is leading to improved quality in clinical trial conduct and associated data across participating sites. |
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| MeSH term(s) | Humans ; Clinical Trials as Topic ; Data Accuracy ; Quality Improvement ; Clinical Trials Data Monitoring Committees ; Reproducibility of Results ; Patient Safety |
| Language | English |
| Publishing date | 2024-02-09 |
| Publishing country | Switzerland |
| Document type | Journal Article |
| ZDB-ID | 2708397-4 |
| ISSN | 2168-4804 ; 2168-4790 |
| ISSN (online) | 2168-4804 |
| ISSN | 2168-4790 |
| DOI | 10.1007/s43441-024-00613-w |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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