Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials.
Ther Innov Regul Sci
; 58(3): 483-494, 2024 May.
Article
en En
| MEDLINE
| ID: mdl-38334868
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 ANDMETHODS:
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 -log10 P-value of the site compared with all other sites) and the other based on the observed metric value associated with each risk signal.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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Ensayos Clínicos como Asunto
/
Mejoramiento de la Calidad
/
Exactitud de los Datos
Tipo de estudio:
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Ther Innov Regul Sci
Año:
2024
Tipo del documento:
Article
País de afiliación:
Bélgica