Screening, Enrollment & Discontinuation Metrics v1.0 Toolkit Released December 8th

Tuesday, December 14, 2021

The Site Selection & Start-Up Process Metric Development Work Group – comprised of more than 250 individuals representing over 60 organizations – has been working collaboratively since October 2019 to develop a series of metric toolkits aimed to:

  • Facilitate comparison / benchmarking across industry
  • Monitor processes and identify process improvement opportunities
  • Provide objective evidence of impact of process improvement efforts

The latest toolkit – Screening, Enrollment & Discontinuation Metrics Toolkit v1.0 – was released December 8. This toolkit replaces similar metrics included in the Clinical Trial Performance Metrics v1.3 toolkit. The work group reviewed those metrics to ensure they align with current processes, support the use of a balanced set of metrics (i.e. measure more than just “time”), and meet today’s data analytic needs. The work group had interesting discussions about the definition of terms such as drop-out, discontinuation and withdrawn as well as leading versus lagging metrics. Many of the metrics are defined at multiple levels – study, country, site – and some of them are identified as possible Key Risk Indicators for use as part of Risk-Based Quality Management. The work group is planning to publish additional metrics for site identification & selection and for Regulatory & IEC/IRB submission & approval in 2022. Additional site selection & study start-up metric toolkits available to members include Site Contracting Metrics v1.1 and Site Activation Milestone Metrics v1.0. Please contact Terry Holland if you need assistance locating the toolkits.