Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/38844
Title: Does Central Monitoring Lead to Higher Quality? An Analysis of Key Risk Indicator Outcomes
Authors: de Viron, Sylviane
Trotta, Laura
Steijn, William
Young, Steve
BUYSE, Marc 
Issue Date: 2022
Publisher: SPRINGER HEIDELBERG
Source: Therapeutic Innovation & Regulatory Science, 57 (2), p. 295-303
Abstract: Background Central monitoring, which typically includes the use of key risk indicators (KRIs), aims at improving the quality of clinical research by pro-actively identifying 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. However, there has to-date been a relative lack of direct quantitative evidence published supporting the claim that central monitoring actually leads to improved quality. Material and Methods Nine commonly used KRIs were analyzed for evidence of quality improvement using data retrieved from a large central monitoring platform. A total of 212 studies comprising 1676 sites with KRI signals were used in the analysis, representing central monitoring activity from 23 different sponsor organizations. Two quality improvement metrics were assessed for each KRI, one based on a statistical score (p-value) and the other based on a KRI's observed value. Results Both KRI quality metrics showed improvement in a vast majority of sites (82.9% for statistical score, 81.1% for observed KRI value). Additionally, the statistical score and the observed KRI values improved, respectively by 66.1% and 72.4% on average towards the study average for those sites showing improvement. Conclusion The results of this analysis provide clear quantitative evidence supporting the hypothesis that use of KRIs in central monitoring is leading to improved quality in clinical trial conduct and associated data across participating sites.
Notes: de Viron, S (corresponding author), CluePoints SA, Ave Albert Einstein 2a, B-1348 Louvain La Neuve, Belgium.
sylviane.deviron@CluePoints.com
Keywords: Statistical monitoring;Central monitoring;Risk-based quality management monitoring;RBM;RBQM;Key risk indicators;KRI;Site performance
Document URI: http://hdl.handle.net/1942/38844
ISSN: 2168-4790
e-ISSN: 2168-4804
DOI: 10.1007/s43441-022-00470-5
ISI #: 000870935600003
Rights: The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
Category: A1
Type: Journal Contribution
Validations: ecoom 2023
Appears in Collections:Research publications

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