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Tytuł:
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Evaluation of Data Errors and Monitoring Activities in a Trial in Japan Using a Risk-Based Approach Including Central Monitoring and Site Risk Assessment.
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Autorzy:
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Kondo H; Clinical Operation Steering Department, A2 Healthcare Corporation, Tokyo, Japan. .; Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan. .
Kamiyoshihara T; Clinical Development Department I, A2 Healthcare Corporation, Tokyo, Japan.
Fujisawa K; Clinical Data Science Department, Pharmaceutical Division Kowa Company, Ltd., Tokyo, Japan.
Nojima T; Clinical Data Science Department, Pharmaceutical Division Kowa Company, Ltd., Tokyo, Japan.
Tanigawa R; Clinical Development Department, Pharmaceutical Division Kowa Company, Ltd., Tokyo, Japan.
Fujiwara H; Clinical Development Department, Pharmaceutical Division Kowa Company, Ltd., Tokyo, Japan.
Suganami H; Clinical Data Science Department, Pharmaceutical Division Kowa Company, Ltd., Tokyo, Japan.
Hayashi Y; Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.; Datascience Division, A2 Healthcare Corporation, Tokyo, Japan.
Yamaguchi T; Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.; Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
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Źródło:
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Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2021 Jul; Vol. 55 (4), pp. 841-849. Date of Electronic Publication: 2021 Apr 19.
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Typ publikacji:
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Journal Article; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Publication: 2020- : Cham, Switzerland : Springer International Publishing
Original Publication: Thousand Oaks, CA : Sage Publications, [2013]-
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MeSH Terms:
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Data Accuracy*
Research Personnel*
Cost Savings ; Humans ; Japan ; Risk Assessment
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References:
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Br J Clin Pharmacol. 2015 Apr;79(4):660-8. (PMID: 25327707)
Clin Trials. 2017 Dec;14(6):584-596. (PMID: 28786330)
Ther Innov Regul Sci. 2014 Nov;48(6):671-680. (PMID: 30227471)
Ther Innov Regul Sci. 2020 Jan;54(1):139-143. (PMID: 32008243)
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Contributed Indexing:
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Keywords: Central monitoring; RBM; Risk-based monitoring; Site risk assessment
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Entry Date(s):
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Date Created: 20210420 Date Completed: 20210705 Latest Revision: 20210710
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Update Code:
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20240105
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PubMed Central ID:
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PMC8238712
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DOI:
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10.1007/s43441-021-00286-9
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PMID:
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33876398
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Background: Risk-based monitoring (RBM) is a slow uptake in some trial sponsors. There are three main reasons for this. First, there is the fear of making large investments into advanced RBM technology solutions. Second, it is considered that RBM is most suitable for large, complex trials. Third, there is the fear of errors in both critical and non-critical data, appearing as reduced on-site monitoring is being conducted.
Methods: Our RBM team identified, evaluated, and mitigated trial risks, as well as devised a monitoring strategy. The clinical research associate (CRA) assessed the site risks, and the RBM team conducted central monitoring. We compared all data errors and on-site monitoring time between the partial switching sites [sites that had switched to partial source data verification (SDV) and source data review (SDR)] and the 100% SDV and SDR sites (sites that had implemented 100% SDV and SDR).
Results: Partial switching sites did not require any critical data correction and had a smaller number of data corrections through on-site monitoring than the 100% SDV and SDR sites. The RBM strategy reduced the on-site monitoring time by 30%.
Conclusions: The results suggest that RBM can be successfully implemented through the use of site risk assessment and central monitoring with practically no additional investment in technology and still produced similar results in terms of subject safety and data quality, as well as the cost savings that have been reported in global complex studies.
