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Missing the Target—When Monitors Work Harder but Not Smarter

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Geeks Talk Clinical contributor—often exhorts his fellow “Medidatians” to not simply work hard, but most importantly to work smart. While I’m sure he fully expects that we will continue to work with the same high level of passion as before, what he really wants is for us to seek out opportunities to increase the impact of our collective efforts. And indeed what I see at Medidata is a culture marked by innovation and high energy that has been very receptive and responsive to Glen’s message. A similar theme has also been heard in recent years across many clinical R&D organizations, often couched in the phrase “Do More With Less!” that inevitably shows up plastered on office knickknacks like coffee mugs, paperweights and mouse pads. Unfortunately—and typical of the conservative industry that many of us have come to know—these campaigns have not yet translated into aggressive transformation of the site monitoring process, one of the two biggest cost drivers in clinical research today. Earlier this year in a contribution to the Data Analytics blog on Applied Clinical Trials, we presented metrics highlighting the trend in the percentage of source document verification (SDV) coverage (i.e., percent of eCRF data targeted for SDV). In particular, we noted that the metric has been decreasing slightly over the past four years, presumably related to early adoption of a more targeted, risk-based monitoring strategy—of which we at Medidata are big proponents. While the overall decrease has been relatively modest, one might expect that the amount of on-site time required by site monitors should correspondingly start decreasing. Unfortunately, this month’s Insights metric tells a different story. Using the Medidata Insights metrics warehouse—now comprising nearly 2,500 studies from 65 sponsor organizations—we looked into the annual trend of two critical monitoring efficiency metrics, focusing on just Phase II/III studies from 2008-2011:

  1. Monitoring On-Site Rate—the average number of on-site monitoring days per site per year
  2. SDV Velocity—the average number of eCRF data points source document verified per on-site day

The data shows that site monitors are spending increasingly more days on-site per year—up 11%—and performing increasing amounts of SDV during each on-site day—up 13%! Perhaps this increasing burden—and cost—of site monitoring and SDV can be attributed to the increasing complexity of protocols and eCRFs that we’ve also observed in recent years (and recent blogs). Either way, it sure appears that monitors are indeed working harder. But it is another reminder of the need to move more aggressively towards a targeted, risk-based monitoring paradigm. On the heels of the FDA draft guidance last August firmly endorsing such an approach, the clear opportunity presents itself to work smarter and do more with less! We’re very interested to hear your take on these observed trends and to hear what your organization is doing to work smarter. Please also stay tuned as we continue to dig deeper into the Insights data through 2012. More about Stephen Young

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