Current Edition

Statistically Speaking – Why a Hybrid of Centralised

Statistical Monitoring and Key Risk Indicators
could be the Answer for Risk-based Monitoring
The industry is at a crossroads when it comes to data-driven
monitoring practices in clinical trials. While traditional
approaches still dominate, new methodologies are increasingly
implemented that facilitate more efficient trial delivery and
hold the potential to further reduce risk, while improving
patient safety and data quality. Until recently, risk-based
monitoring (RBM) systems have relied widely on the use of
key risk indicators (KRIs) to identify anomalies in data and
deviations in study conduct, and to allow research sponsors to
identify performance issues at investigative sites. Marc Buyse
of CluePoints Inc. looks at how the use of CSM techniques, in
conjunction with KRIs, can enhance monitoring strategies, and
outline a pragmatic workflow that may help sponsors better
mitigate risk.