Abstract
Background Monitoring in randomized trials is recommended as part of International Conference on Harmonisation Good Clinical Practice standards. On-site monitoring in multicentre trials is common but is costly and can be inefficient. Central statistical monitoring can be used to detect unusual data patterns, identify intentional or unintentional trial misconduct, and to prioritise on-site visits and additional training. Motivated by an ongoing international multicentre clinical trial of over 25,000 randomized participants with electronic data capture, we developed key risk indicator (KRI) methods for central statistical monitoring in multicentre trials.
Highlights
Monitoring in randomized trials is recommended as part of International Conference on Harmonisation Good Clinical Practice standards
Motivated by an ongoing international multicentre clinical trial of over 25,000 randomized participants with electronic data capture, we developed key risk indicator (KRI) methods for central statistical monitoring in multicentre trials
Statistical monitoring of KRIs such as the rate of serious adverse event reporting, compliance with study treatment visit duration and blood results may be informative for identifying poor site performance in randomized trials
Summary
Monitoring in randomized trials is recommended as part of International Conference on Harmonisation Good Clinical Practice standards. On-site monitoring in multicentre trials is common but is costly and can be inefficient. Central statistical monitoring can be used to detect unusual data patterns, identify intentional or unintentional trial misconduct, and to prioritise on-site visits and additional training. Motivated by an ongoing international multicentre clinical trial of over 25,000 randomized participants with electronic data capture, we developed key risk indicator (KRI) methods for central statistical monitoring in multicentre trials
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