Looking to History vs. Focusing on the Current Trial

Editor’s Note: This is the second post in a three-part series. You can read the first post here, and the third post here.

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:

• Without process improvement, supporting technology and staff retraining, once the project succeeds in defining KPIs and KRIs, how will it be possible to utilize them in a manner that substantially improves trial management, execution and data quality?

• Does overwhelming emphasis on the historical perspective obscure the paramount importance of developing KPIs and KRIs as management tools to address the unique operational issues of each individual trial, including issues that emerge only during execution of the current trial?

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.]

This post first appeared on the Health Decisions blog, Trials Without Tribulations.