Risk-Based Monitoring: Pilot Projects, Functional Service Providers, and Integrated Solutions


Applied Clinical Trials

Risk-based monitoring provides an opportunity to make the work of CRAs more interesting.

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

An informative recent post by Moe Alsumidaie of Annex Clinical on the Applied Clinical Trials blog, “How Bristol-Myers Squibb is doing Risk-Based Monitoring,” briefly described what the BMS risk-based monitoring pilot project has accomplished as well as issues encountered during implementation.

It is nice to see a big company like BMS getting involved in Risk-Based Monitoring. However, the concluding paragraph of the blog post is a reminder of the challenges that big companies face in the transition to any new technology. It sounds as though the BMS pilot project was laboring under constraints of infrastructure, organization and culture. The concluding paragraph of the post quotes Thomas Verish, Group Director of Data Operations Services, as indicating that the next steps for BMS in the transition to RBM will involve “focusing on educating and developing people, process improvement, identifying technological needs, and sharing experiences with the RBM pilot.”

While these steps are essential to the success of RBM, it is surprising to an outsider that, in 2013-2014, BMS did not consider three of the “next steps” listed to be essential first steps in their RBM pilot project. It is hard to imagine how any RBM implementation could succeed without process improvement, strong supporting technology and staff retraining and development.

Furthermore, the blog post mentioned staff resistance at BMS to changes in roles and responsibilities as a hurdle early in the pilot project. One factor in addressing such resistance is providing staff with improved processes and supporting technology to carry out their new responsibilities. Risk-based monitoring provides an opportunity to make the work of CRAs more interesting, both because it enables them to focus on data and processes most important to project success and because RBM enables CRAs to function more as site managers and less as data checkers (at least in RBM implementations that involve appropriate process improvements and technology). RBM can and should be more appealing to CRAs, not less.

[A follow-up to this post will look at the importance of historical vs. prospective focus in risk-based monitoring.]

This post first appeared on the Health Decisions blog, Trials Without Tribulations http://www.healthdec.com/blog/


Michael Rosenberg, MD, MPH, is CEO, Health Decisions, Inc.

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