Metrics

In implementing a RBM plan, it’s important to define metrics in order to measure success. According to the TransCelerate model, key metrics measure changes in quality, timeliness of data collection and query resolution, and efficiency of trial operations affected by RBM, on an ongoing basis and after the closure of a study.

According to a blinded survey, TransCelerate sponsor companies that have implemented RBM have reported using several additional metrics to evaluate Centralized monitoring success, including data quality, frequency of On-Site visits, protocol deviations, serious adverse event (SAE) reporting rates, and site audit findings.

Centralized monitoring, as proposed by TransCelerate, is still new. A great deal of insight has been gleaned thus far – but there are many more insights and lessons to come. As the industry further adopts RBM practices into clinical trials, results and metrics will continue to inform a movement towards RBM.