Risk-Based Monitoring – Part Two In Depth Review

What Do Risk-Based Monitoring and Patient Engagement Have in Common?

Has FDA Guidance on Risk-based Monitoring Impacted SDV Coverage Yet?

In a recent blog, we presented data highlighting the trend in the percentage of source document verification coverage (i.e., percent of eCRF data targeted for SDV) and in particular observed that it has been decreasing slightly over the past four years, presumably related to early adoption of targeted, risk-based monitoring strategies. While the overall decrease has been relatively modest to-date, one might expect that the amount of on-site time required by site monitors should correspondingly start decreasing.  

But this month';s Insights graph tells a different - and somewhat troubling - story. Using the Medidata Insights metrics warehouse- now comprising nearly 2,500 studies from 65 sponsor organizations - annual trends were computed and graphed of two critical monitoring efficiency metrics for Phase II/III studies:   

Monitoring on-site rate—the average number of on-site monitoring days per site per year

SDV velocity—the average number of eCRF data points SDV'd per on-site day

The data shows that site monitors are spending increasingly more days on-site per year, and performing increasing amounts of SDV during each on-site day. This increasing burden—and cost—of site monitoring and SDV can be attributed to the increasing complexity of protocols observed in recent years. It is another reminder of the serious challenges facing clinical R&D organizations and the need to move more aggressively towards a targeted, risk-based monitoring paradigm.  

Medidata is very interested to hear your take on these observed trends. Please also stay tuned as we continue to dig deeper into the Insights data through 2012. 


 Monitoring rates in Phase II-III trials, 2008-2011.

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Applied Clinical Trials-07-01-2012

The percentage of source document verification coverage has been decreasing slightly over the past four years. Therefore, the amount of on-site time required by site monitors should also start decreasing.