Are Regulators Using RBM Tools?

July 31, 2013
Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at lhenderson@mmhgroup.com.

Applied Clinical Trials

A recent Twitter follower asked in regard to RBM technology, "Is there any experience w/regulators utilizing tool data as a roadmap to ID trouble sites during inspections?"

A recent Twitter follower asked in regard to RBM technology, "Is there any experience w/regulators utilizing tool data as a roadmap to ID trouble sites during inspections?"

Our most recent profiles of new technology players in the RBM market are Marc Buyse(left), founder, Cluepoints and Courtney McBean(right), co-founder Blueprint Clinical, both offering analytical tools and consulting services for sponsors to address risk-based monitoring.

So we took the question to them. The short answer is, “No, regulators aren’t utilizing tool data.” But for more insight, read on:

McBean answered:
“We haven't seen regulators use a tool such as Compass to identify sites. Compass is intended as an internal operational tool with the supporting data from EDC and additional trial management databases and documents such as CTMS and monitoring reports. While it’s not intended to be an audit support tool, we have built it to support such an event--all historical data can be presented in sponsor report to assist them in an audit. Those reports can be customized to the sponsor's preferences as well.

While targeting sites could be a possibility if regulators were given access to the tool; I think the use of a tool like ours goes farther in demonstrating the sponsor has better management of the trial. Our tool, Compass, follows a Quality Systems Management or Risk Management methodology to managing site performance--the more a study aligns with a QSM methodology the more control and understanding they will have of site performance and the more they will align with the FDA's perspective on trial management.

The benefit of aligning with a proven and endorsed methodology like QSM, not only for increased quality and audit assurance, but also for time and resource savings, outweighs the risk.”

And Buyse responded: “There is no evidence as yet but, from our experience, there are now a number of sponsors using these Intelligent Statistical Monitoring techniques as a major part of their RBM initiatives to detect potential landmines in their data. This approach will certainly be evident to regulatory authorities and is the one that they are actively encouraging in their own RBM guidelines. It is clear that from the sponsor and regulatory perspective that the approach makes sense and I think the regulators will take a far more favorable view of a monitoring plan that uses an objective tool, such as CluePoints, as compared with other approaches that are far more subjective. CluePoints finds data issues. Whether these issues put the study at risk is another matter, but data issues are data issues regardless of how you found them. I believe regulators are going to welcome this statistical approach to RBM for that very reason.”

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