ISR Reviews Report "Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing"

SPOTLIGHT EVENTRisk-Based Monitoring – Beyond Theory In-Depth ReviewMarch 13, 2014
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The April edition of Applied Clinical Trials contained the article “What Does the Future Hold for Clinical Monitoring?” in which Industry Standard Research’s (ISR) President, Andrew Schafer, examined a range of industry perspectives across a number of alternative designs and monitoring processes. With ISR’s newest market research report (“Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing”) Mr. Schafer is back to draw comparisons and share data from their latest survey.

What’s in a name?

Well, if you ask marketing and branding experts, they will tell you a name can be everything. At ISR, we have found it interesting that someone in the pharmaceutical industry named a process for monitoring investigative sites and patient data “risk-based monitoring.” For an industry that is notoriously risk-averse and highly regulated, we would have bet against a solution named “risk-based monitoring” gaining traction. But it has.

How does the industry’s awareness and interest in RBM compare to other monitoring models? While not as widely known as triggered or traditional on-site monitoring, 95% of respondents report that RBM is gaining momentum in their organization. But why are RBM trials gaining momentum? In two words: Lower Cost. The vast majority of respondents who have experience with RBM studies indicated the catalyst for running these trials was to lower the monitoring costs. And CROs take note: 72% of respondents who have direct RBM experience indicated their organization does save money using risk-based monitoring.

The awareness of and interest in RBM is relatively high. Sponsors are, or should be, doing their due diligence on the topic. They are looking for both internal subject-matter experts across many different disciplines within their organization and for CROs who not only have experience operationally executing RBM studies, but they are looking for CROs who can/ will input on the design and strategies surrounding them.

About ISR’s report: ISR’s “Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing” surveyed 78 individuals from sponsor organizations with responsibility for the design, conduct, and outsourcing of RBM trials. This report offers insights into sponsors’ interests and use of RBM models, factors that are driving adoption, and study types seen as best fits for these types of studies.

More information about ISR’s report is available at http://www.isrreports.com/product/risk-based-monitoring-industry-guidance-on-adoption-use-and-outsourcing/.