In early 2015, Metrics Champion Consortium (MCC) member organizations – sponsors and electronic Clinical Outcome Assessment (eCOA) vendors – requested that the MCC facilitate the development of a standard set of eCOA performance metrics to include in the growing MCC library of clinical metric sets. They believed that the time was right to establish an initial set of measures since the use of eCOA (sometimes referred to as electronic Patient Reported Outcomes – ePRO) has continued to grow and evolve. This growth is partially due to it being one of several tools that helps support the current emphasis on patient-centered clinical research.
In response, MCC launched the eCOA Performance Metrics Initiative to define a standardized set of eCOA performance metrics to be used by clinical trial sponsors, CROs and eCOA vendors to assess the timeliness, quality and effectiveness of the eCOA setup and data collection services. Utilization of these metrics will enable organizations to understand how well the process is being executed and managed throughout study start-up, conduct and closeout.
During the first phase of metric development process, MCC worked exclusively with the eCOA Leadership Team – comprised of representatives from ten member organizations (sponsors, eCOA vendors, CROs) – to establish the foundation on which to build the metric set. Specifically, they used the MCC Metrics Development Process to develop an eCOA Process Map, define nine eCOA Critical Success Factors (CSFs) and draft 28 Key Performance Questions (KPQs). In the final phase of the development process, MCC members will define a set of metrics that answer the high priority KPQs.
Additionally, members of the Leadership team hosted an eCOA Basics webinar to provide MCC members with an overview of eCOA that included topics such as, Types of eCOA measures, the eCOA Regulatory Landscape, and the Impact on Data Quality and Subject Retention. MCC members are invited to visit the Education and Training section of the MCC Member Portal to view the archived recording of the session [free of charge] as well as additional information about the eCOA Metrics Initiative.
MCC Member Feedback Survey
MCC is conducting a brief survey designed to gather information from MCC Member organizations about the eCOA CSFs and KPQs. If you are a MCC member and wish to participate in the guided review of the eCOA CSFs and KPQs, log onto the MCC Member Portal to see the list of open surveys which includes, MCC Member Guided Review of eCOA/ePRO Key Performance Questions (KPQs). Survey results will be shared with a now-forming MCC eCOA Working Group that will make recommendations on the initial set of eCOA metrics. You can signup to be part of this working group at the end of the survey.
To learn more about membership options or to register to become a member of the MCC, please CLICK HERE or contact Terry Holland. MCC Members are invited to contact Customer Service for assistance with establishing user accounts and accessing the MCC Member Portal.