I just returned from the SCOPE meeting in Orlando. I attended to learn the “state of the industry” on Risk Based Monitoring (RBM) and data analytics. If you are not familiar with this conference, there is a caveat. Only Sponsors and Exhibitors are allowed as speakers; this slants the view. Still, there was a lot to learn.
- Most CROs that presented and that I talked to (primarily large CROs) implemented RBM within their monitoring group without incorporating the data strategies for eSource that were released and finalized in 2013 concurrently with the RBM Guidance. These include the guidance to collect data using the principles of ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) that allow immediate access to data for central review without waiting for transcription. Takeaway: If you don’t include the data strategy, you will always be saddled with those pesky source documents that hamper adoption of a true Risk-Based monitoring approach. The greatest benefit is gained by a combined data collection and oversight strategy.
- Many big Pharmas that contributed to the Transcelerate Guidance for RBM outsource their trials to the big CROs. This means the methods recommended are primarily based on the CRO adoption model, which still has a large component relying on onsite visits. This isn’t surprising because onsite visits are the major source of revenue for CROs. Takeaway: there are many approaches to adopting RBM and the Transcelerate approach may not be the best for you.
- While not discussed much, the RBM group highlighted three areas for focus:
- Recognizing the importance of senior leadership and change management in the adoption of RBM
- Revising the Request For Proposal (RFP) process to reflect the new model for trial oversight. Many/most RFP’s still ask for estimates based on SDV, estimates of time to do CRF review, and other aspects of trial management which do not incorporate the aspects of RBM oversight needed. Takeaway: Working with your Outsourcing group is critical. The “buckets” of spending will differ and the RFP should be flexible enough to recognize these process changes.
- Revising the trial management model to focus site performance on critical issues, protocol compliance, and subject safety instead of questionable metrics such as number of pages SDV’ed and number of queries open. Takeaway: This is a good first step we take even further. It is critical to train Trial Managers to understand quality management (i.e., identify critical issues, perform root cause analysis, and evaluate the resolution of issues) for the industry to truly adopt the principles of RBM.
- The love affair with Key Risk Indicators (KRI) may be waning (YEAHHH!). IQVia noted (what we, and others, have identified) that there is a lot of noise with KRIs. We have also found KRIs are blunt, lagging indicators and outliers are identified much later than using other methods to identify high-risk sites. If you wait for a KRI to become critical, you have missed a big opportunity to prevent errors rather than correct them.
The Abbott Nutrition RBM team provided a wonderful example of adopting RBM within a company. They discussed senior leadership championship of the program, the importance of focusing on change management in the process, and used a cross-functional team including Clinical, Data Management, and Statistics in their programs. Kudos to the presenters: Sonya Verrill, Geraldine Baggs, Ph.D., Dione Smart, Xiaosong (Sue) Zhang MS, MAS, and their whole team.
Yiwen Sun from Samumed also presented a small company’s approach to implementing ICHE6(R2) and RBM.
Nicole Stansbury from PPD provided real life examples of its RBM adoption; saying they found a 16% decrease in critical major findings, 17% better detection of significant deviations, 12-15% decrease in monitoring costs with a decrease of 6-15% in total trial costs even with Central Monitoring Costs.
Finally, a plea from me: I am a member of an Expert Advisory Panel to the FDA on RBM. The FDA wants to identify and understand the barriers to RBM adoption. This is a great opportunity to make your voice heard. Please complete a brief survey at www.surveymonkey.com/r/RBMBarriers
. Please forward this link to all your colleagues who are also interested in letting the FDA panel know their opinions.