A statistical approach to central monitoring of data quality in clinical trials.
Clin Trials
; 9(6): 705-13, 2012 Dec.
Article
em En
| MEDLINE
| ID: mdl-22684241
ABSTRACT
BACKGROUND:
Classical monitoring approaches rely on extensive on-site visits and source data verification. These activities are associated with high cost and a limited contribution to data quality. Central statistical monitoring is of particular interest to address these shortcomings.PURPOSE:
This article outlines the principles of central statistical monitoring and the challenges of implementing it in actual trials.METHODS:
A statistical approach to central monitoring is based on a large number of statistical tests performed on all variables collected in the database, in order to identify centers that differ from the others. The tests generate a high-dimensional matrix of p-values, which can be analyzed by statistical methods and bioinformatic tools to identify extreme centers.RESULTS:
Results from actual trials are provided to illustrate typical findings that can be expected from a central statistical monitoring approach, which detects abnormal patterns that were not (or could not have been) detected by on-site monitoring.LIMITATIONS:
Central statistical monitoring can only address problems present in the data. Important aspects of trial conduct such as a lack of informed consent documentation, for instance, require other approaches. The results provided here are empirical examples from a limited number of studies.CONCLUSION:
Central statistical monitoring can both optimize on-site monitoring and improve data quality and as such provides a cost-effective way of meeting regulatory requirements for clinical trials.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Interpretação Estatística de Dados
/
Estudos Multicêntricos como Assunto
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Idioma:
En
Revista:
Clin Trials
Assunto da revista:
MEDICINA
/
TERAPEUTICA
Ano de publicação:
2012
Tipo de documento:
Article
País de afiliação:
Bélgica