A statistical approach to central monitoring of data quality in clinical trials

Ctj.sagepub.com: Jume 8, 2012.

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. Read More