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.
DemingWE. Out of the Crisis. Cambridge, MA: MIT Press; 2000.
2.
BrosteanuOHoubenPIhrigK. Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials. Clin Trials. 2009;6(6):585–596.
3.
ChalmersTCSmithHBlackburnB. A method for assessing the quality of a randomized control trial. Controlled Clin Trials. 1981;2:31–49.
4.
PfadtAVickiSRomanczykRGWheelerDJRomanczykRG. Applying statistical process control to clinical data: an illustration. J Appl Behav Anal. 1992;25(3):551–560.
5.
GreenRS. The application of statistical process control to manage global client outcomes in behavioral healthcare. Eval Program Plann. 1999;22(2):199–210.
6.
SvolbaGBauerP. Statistical quality control in clinical trials. Control Clin Trials. 1999;20(6):519–530.
7.
BenneyanJC. Number between g-type statistical quality control charts for monitoring adverse events. Health Care Manage Sci. 2001;4(4):305–318.
8.
VardakiaMPapageorgiouaHPentarisbF. A statistical metadata model for clinical trials’ data management. Comput Methods Programs Biomed. 2009;95(2):129–145.
9.
RostamiRNahmMPieperCF. What can we learn from a decade of database audits? The Duke Clinical Research Institute experience, 1997—2006. Clin Trials. 2009;6(2):141–150.
MohammeMA. Statistical process control: using statistical process control to improve the quality of health care. Qual Saf Health Care. 2004;13(4):243–245.
19.
BenneyanJCLloydRCPlsePE. Statistical process control as a tool for research and healthcare improvement. Qual Saf Health Care. 2003;12(6):458–464.
20.
MortonAP. The use of statistical process control methods in monitoring clinical performance. Int J Qual Health Care. 2003;15(4):361–362.
21.
Harry SmithJBlackburnBSilvermanB. A method for assessing the quality of a randomized control trial. Control Clin Trials. 1998;2(1):31–49.
