Clinical Trial Performance Metrics

The JHU-TIC are involved with the TIN Metrics Working Group, whose aim is to identify a framework for collecting and reviewing trial performance metrics that can be used to assess and evaluate clinical trial performance for studies that are approved for services or consultations within the TIN. We will also use these metrics to evaluate the impact of Operational Innovations within the TIN.

Specific Objectives of this WG:

  1. Review operational hypotheses and implement corresponding metrics to assess these OHs
  2. Identify the metrics to be collected for full service CCC activities vs discrete services
  3. Identify data definitions used across TICs/RICs for identified metrics, and harmonize these definitions
  4. Identify criteria for potential central database for collection and reporting
  5. Decide if and how data should be collected from other CCCs
  6. 6. Identify process improvement goals/best practices associated with specific metrics to understand and improve performance

The JHU-Tufts TIC, in collaboration with the Tufts Center for the Study of Drug Development completed a Demonstration Project to identify key priority metrics that indicate clinical trial performance. Using both prospective landscape scan and retrospective regression analysis, we identified a set of 11 metrics, listed in the table below. These metrics will be used as the basis for identifying key metrics to collect for full implementation and service, and will be mapped to the TIN Operational Innovations to ensure we are correctly evaluating how the TIN is improving the quality, operational efficiency and adding innovation to clinical trials.

Priority Clinical Trial Performance Metrics

1 Time from initial contract received to fully executed contract
2 Time from IRB package submitted to IRB approval letter
3 Percentage of actual randomized patients to expected patients
4 Time from protocol available to First Patient First Visit (FPFV)
5 Site activation to FPFV
6 Site activation to Last Patient First Visit (LPFV)
7 Screen Fail ratio
8 Percent of consented patients that are randomized into the study
9 Percent of randomized patients that discontinue the study
10 Number of significant protocol deviations
11 Number of queries per eCRF page