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Authors

  1. Novitzke, Jill
  2. Martin, Renee
  3. Palesch, Yuko Y.
  4. Qureshi, Adnan I.
  5. for the ATACH investigators

Abstract

Site activation activities, including institutional review board and contract approvals, are an integral part of multicenter clinical trials. Our objective was to report the time invested in completing the required site activation activities. Data from our experience are relevant for planning purposes by prospective coordinating centers in optimizing time and financial resources. We analyzed data from the Antihypertensive Treatment of Acute Cerebral Hemorrhage trial, which collected details about the activities and time in hours involved with initiating each site. We determined the amount of time required for each of the following start-up tasks: site assessment and protocol feasibility, contract finalization and approval, institutional review board approvals, regulatory files, and protocol training for site investigators and coordinators. We also calculated the number of months expended to complete all of the required tasks from initial site assessment to readiness for enrolling participants. Data from all 12 clinical sites were analyzed. The average time for a site to complete all activities was 196 hours over the course of 11 months. The completion process ranged from a period of 6-22 months among the sites because of varying site-specific edits, available staff, and other delays. The contracts and budget portion of the site activation process was considerably more time intensive than the other activities. Furthermore, a negative correlation existed between the number of months to initiate a site and the number of participants that site enrolled. Analysis of the data from the Antihypertensive Treatment of Acute Cerebral Hemorrhage trial suggests that the time required to prepare a site for readiness to enroll participants is considerable. Allotting sufficient time for completion of site start-up activities is crucial to positioning clinical coordinating centers to succeed in meeting enrollment goals in harmony with established timetables. Clinical trial registration: ClinicalTrials.gov identifier NCT00415610.