Pilot test of an accrual Common Metric for the NIH Clinical and Translational Science Awards (CTSA) Consortium: Metric feasibility and data quality

Failure to accrue participants into clinical trials incurs economic costs, wastes resources, jeop-ardizes answering research questions meaningfully, and delays translating research discoveriesinto improved health. This paper reports the results of a pilot test of the Median Accrual Ratio(MAR) metric developed as a part of the Common Metrics Initiative of the NIH’s NationalCenter for Advancing Translational Science (NCATS) Clinical and Translational ScienceAward (CTSA) Consortium. Using the metric is intended to enhance the ability of theCTSA Consortium and its“hubs”to increase subject accrual into trials within expected time-frames. The pilot test was undertaken at Tufts Clinical and Translational Science Institute(CTSI) with eight CTSA Consortium hubs. We describe the pilot test methods, and resultsregarding feasibility of collecting metric data and the quality of data that was collected.Participating hubs welcomed the opportunity to assess accrual efforts, but experienced chal-lenges in collecting accrual metric data due to insufficient infrastructure and inconsistentimplementation of electronic data systems and lack of uniform data definitions. Also, the metriccould not be constructed for all trial designs, particularly those using competitive enrollmentstrategies. We offer recommendations to address the identified challenges to facilitate progressto broad accrual metric data collection and use.