Perhaps the BMS pilot project focused so intensely on gathering historical information as a basis for developing risk-based analytical assessments, KPIs and KRIs that the project ream had little opportunity to address process improvement, technology development and staff training and development. If so, this raises two questions:
Historical information and analytical foundations for RBM are important, but, in my view, RBM is about proactively managing each individual trial to quality and efficiency goals. Prospective considerations based on timely information are more important to RBM success than the historical record. Effectively managing the current trial involves far more than having a central analytical staff identify KPIs and determine triggers for monitoring visits. Central staff should be managing the study in real time, continuously addressing issues in the field and resolving many issues without the need for site visits. Properly implemented, RBM is not a discrete activity but an integral component of proactive trial management.
[The concluding post in this three-part series will consider cost and quality implications of risk-based monitoring.]