Johns Hopkins Statistical and Safety Resource Center-HEAL PAIN ERN

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ABSTRACT The JHU-Tufts TIC is an established, functioning team of multisite trial PIs, experienced lead managers, administrators, and scientists at both Johns Hopkins University (JHU) and Tufts University. BIOS, a JHU trials research group, will operationally convene this group and provide staff to execute the required Statistical and Safety Resource Center program and its specific assigned tasks in the areas of statistics, safety, and DSMB management. Our joint expertise, developing and managing trials in these specified areas extends well beyond the last three years of work on the ongoing HEAL Pain ERN studies with our group having served as clinical coordinating centers and data coordinating centers for dozens of large multi-centered clinical trials at various NIH ICs. Together with our partners at Duke, Utah, and Vanderbilt, we will support the awardee teams for the new sickle cell trials in the same collaborative and comprehensive manner that has been demonstrated for the ongoing five trials currently awarded as part of the HEAL Pain ERN initiative.