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The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study

The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study

Each of the 3 sites were given a separate randomization code, and participants at each site were randomized using a Bayesian Adaptive Design detailed by Brown et al [15]. Subsequent adaptations and adapted randomization schedules were appended to each site within CRIS. The ability of CRIS to ensure accrual equality across study sites was assessed using a Gini coefficient.

Dinesh Pal Mudaranthakam, Alexandra Brown, Elizabeth Kerling, Susan E Carlson, Christina J Valentine, Byron Gajewski

JMIR Form Res 2021;5(12):e30368