Clinical Trials Insight Article Reveals New Clinical KPI Survey Findings

Monthly Archives: October 2016

Clinical Trials Insight Article Reveals New Clinical KPI Survey Findings

Thursday, October 27, 2016

Ken Getz—MCC owner, Director of Sponsored Research at the Tufts CSDD, and Chairman of CISCRP—discussed the new KPI survey findings in his article “Finally, Standardized KPIs are Front and Center” in Applied Clinical Trials Online.  The article explains the various challenges organizations have been facing in the collection and application of relevant metrics, the main factors driving the widespread adoption of standardized metrics, and how the majority of organizations are using KPIs.

Read Ken Getz’s article on Applied Clinical Trials Online

Please visit MCC Survey Reports for more information.

About Metrics Champion Consortium (MCC)

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

MCC Conducting Final Clinical Trial Performance Metric Reviews for Version 2.0

Tuesday, October 18, 2016

Earlier this year, MCC launched a series of online, metric feedback surveys to gather comments about the Clinical Trial Performance Metrics (CTPM) set (v1.2). This is an exercise that we perform on a 2-3 year cycle to make sure that the metrics remain effective and relevant. To facilitate the review process, MCC grouped the metrics into 13 different subsets or categories – mostly aligning with clinical trial functional areas. These category groupings will be maintained in version 2.0.

Metric Set Realignment

As part of the update process, MCC will re-release the CTPM set in smaller, functional area-specific metric sets.  Each metric set will align with one or more Critical Success Factor, Key Performance Questions (KPQs) and the standardized metrics. Critical Success Factors (CSFs) are those things that an organization / function must do well to be successful. CSFs have been written for 13 different clinical trial functional areas.  KPQs are the questions that will help you determine whether you are achieving the CSF.  The metrics that are part of each set serve the purpose of answering that functional area’s Key Performance Questions.

Functional-Area Working Groups Conducting Final Metric Reviews

The functional-area working groups meeting in Q4 2016 are: Data Management, Study Startup, and Protocol Development.  The objective of each working group is to make final enhancements to the metrics before the set is released as v2.0.  This is an opportunity to influence how the industry will measure performance for each of these functions.

Additional Functional-Area Working Groups to Meet in early 2017. 
Additional functional-area working groups slated to meet in early 2017 include:

Subject Enrollment, Site Selection & Site Management, Site Performance, Drug Supply, Safety, Medical Writing, Quality Assurance, Vendor Oversight, Monitoring, and Financial Oversight.

If you have any questions, please contact Keith Morgenstern.