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Great Design and Risk Based Monitoring
By Penny Manasco - May 30, 2016
James Dyson is my hero. After trying a traditional vacuum cleaner that lost suction as he used it, Dyson saw opportunity and focused his intellectual energy into designing a new approach to vacuuming. He designed a beautiful, efficient, bagless vacuum that none of the major vacuum companies wanted to purchase. And why would they? They made lots of money on replacement bags so why “rock the boat” with a machine that didn’t need a bag. If you have ever used a Dyson vacuum, you know he persevered and I am glad he did.
Personal computers are another example of innovation and disruption. The big mainframe companies were not interested in a product that would disrupt their current business and thus, the big PC makers were Dell and Apple, not IBM, which was a late player in the PC market.
The innovations occurring with the adoption of Risk Based Monitoring (RBM) and Total Quality management in clinical trials have the potential to completely change the industry and the way we do business—but don’t count on the current, major players to bring the innovation, if history is any indication. Source Data Verification (SDV), the former, gold standard of quality oversight after recent data reputed its value, has cost Sponsors billions of dollars and made many of the big CROs into huge moneymakers for their investors, shareholders, and owners. Why would they abandon their lucrative SDV model to make the changes necessary to manage trials remotely? While these companies will adopt some RBM principles, their basic revenue source—routine monitoring visits—will not go away until regulatory and economic forces make them change.
Instead, look to small companies as your leaders and innovators. They see remote oversight of trials as a competitive advantage to run trials more efficiently and increase the safety of subjects participating in trials. These innovators will be more likely to adopt and implement the RBM and Remote Trial Management made possible with today’s technologies.
So ask questions. Why should the answer to site moving into a High Risk range for a Key Risk Indicator be a “knee jerk” response such as “Go to the Site?” The answer should be to explore all the data for that site’s performance and to understand the scope of the issue, if any. Following a complete evaluation, the study team will be much better prepared to move to the next step, performing a root cause analysis and conducting remediation and follow up, if needed. Much of this activity can be done remotely, with the right tools and processes.
We have to think differently about how to design or configure technological solutions to help us collect the data we need to manage trials more comprehensively from remote locations. Doing so will solve many problems—we can do more with less, we can keep our experienced monitors that do not want or like to travel, and we can emulate James Dyson, by adopting a better way, despite what the big players want you to do.