Significant Growth—67% Increase Over Past Two Years—in the Use of RBM in Pivotal Clinical Trials

Thursday, October 20, 2016

Boston, MA., October 20, 2016—Metrics Champion Consortium (MCC)—a trusted partner in the clinical trials industry—announced today a newly published report, “An Updated Look at Risk Assessment and Risk-based Management Practices,’ revealing the industry’s acceptance of risk-based monitoring across all phases of clinical trials and regions. The report also features new content on the use of formal risk assessment as a tool for identifying causes of risk that could affect the collecting of critical data or the performance of critical processes prior to a clinical trial.

Among the key findings:

  • Top sources organizations use for project/protocol review is EDC (83%), CTMS (66%), and Central Labs (60%)
  • Majority of organizations are conducting risk assessments prior to study conduct (69%)—fewer are repeating assessments during study conduct
  • Use of web portals and secure document exchange has increased to 56% in 2015, up from 36% in 2013
  • Top reasons organizations are implementing RBM shifted from reducing monitoring costs-78% in 2013-to improving quality oversight (83%) and data quality (85%) in 2015
  • Traditional 100% SDV monitoring decreased from 75% in 2013 to 62% in 2015

“The significant increase in the use of risk-based monitoring approaches signals that the industry has moved from the early adopter to the early majority innovation adoption phase,” said Linda Sullivan, co-founder and president at the industry group Metric Champion Consortium, author of the new report.  “Additionally, our analysis shows that the data analytic approaches being utilized to support risk management and RBM programs are growing in sophistication and will continue to do so in the next 12 months. Standardizing performance metrics are the linchpin that support these analytic platforms.”

MCC conducted the online survey between November 2015 and January 2016 as a follow-up to the seminal work piloted by MCC in 2013, the first survey to examine organizational approaches and e-data sources driving risk-based monitoring (RBM) programs.
For more information on purchasing the “An Updated Look at Risk Assessment and Risk-based Management Practices,” please email or visit

About Metrics Champion Consortium (MCC)

MCC—a trusted partner in the clinical trials industry—identifies what to measure, how to assess the crucial components of what is changing and how the industry is responding to address these changes to make improvements. MCC continually brings you new insights into the leading trends within the industry.

For more information about MCC metric sets and tools, metric education programs and how you can participate in MCC work groups, please visit

Linda Sullivan