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.
Tuesday, October 18, 2016