An In-Process Scaling Model: A Potential Framework for Data Monitoring Committees and Clinical Trial Quality Improvement

Abstract

This article discusses the application of a statistical process control methodology to improve the quality of real-time clinical trial monitoring, an especially valuable tool for data monitoring committees. This article outlines a method that may have value in bringing a data-based approach using the measures of site performance to define patterns of similarity or dissimilarity between the sites. These can then be used to provide an efficient and objective mechanism to identify those sites for closer scrutiny, monitoring, or further training, either at the end of the study or on an ongoing basis.