Clinical Trial Performance Metrics
The JHU Trial Innovation Center leads the Trial Innovation Network (TIN) Metrics Working Group, whose aim is to identify a framework for collecting and reviewing trial performance metrics 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:
- Review operational hypotheses and implement corresponding metrics to assess these OHs
- Identify the metrics to be collected for full service CCC activities vs discrete services
- Identify data definitions used across TICs/RICs for identified metrics, and harmonize these definitions
- Identify criteria for potential central database for collection and reporting
- Decide if and how data should be collected from other CCCs
- Identify process improvement goals/best practices associated with specific metrics to understand and improve performance
The JHU 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 quality, operational efficiency, and innovation in 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 |
| 5 | Site activation to First Patient First Visit |
| 6 | Site activation to Last Patient First Visit |
| 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 |