Last month finished up with a three day intensive eClinical Forum spring meeting at Philadelphia, hosted by ICON at their North Wales office.
While there were many interesting topics ranging from EDC hosting to electronic source system readiness assessment, my role was to lead the panel discussion on risk based monitoring.
We designed the panel discussion to cover the big picture of RBM, with topics from change management to sharing real world examples of implementing remote monitoring. Our panel members were selected to ensure representatives from pharma and CRO members as well as technology and consulting providers.
If you didnt have the chance to be part of the 2 hour session, here are my top 4 lessons learned from the panel.
1.Change management in risk based monitoring – While there are multiple debates around challenges to implementing risk based monitoring, the biggest challenge for organizations is executing operational change successfully. The topmost barrier towards change management was not cost or quality, it was familiarity and the comfort level of staff with risk based approaches and experience using them in a real project from start to finish.
2.Linking risks with key performance indicators – We clearly see there are two siloed conversations happening in risk based monitoring. We talk about protocol risks which need to be mitigated and addressed. We talk about creating a set of key performance indicators that can be used to detect or monitor risks, but how are these linked to each other? It is key to understand and address the linkage between the two.
3.Metrics – As we hear about different metrics for clinical trial performance, operations team need to focus in on what operational effectiveness means to them. Every metric defined in risk based monitoring should have clear ownership, interpretation, and a guideline on how to react when it goes above and below the set thresholds. Without these elements, simply tracking metrics will not yield the end result expected.
4.Central monitoring real world examples – Central monitoring allows early detection of trial risks. The top risk indicators that were identified during central monitoring in one of the projects discussed were late eDC data entry, potential lost to follow up or withdrawn patients and low SAE reporting. A process methodology towards performing a root cause analysis for the detected risk and decision making approach yields the best results. Moreover, a site with a red flag doesn’t turn green within a month. The results are seen over the long run; it can sometimes take as much as 6 months for a site to change their performance from red to green.