Johns Hopkins Statistical and Safety Resource Center-HEAL PAIN ERN

摘要 JHU-Tuft TIC是一支成熟的、运作良好的多站点试验PI团队，经验丰富 约翰·霍普金斯大学(JHU)的首席经理、行政人员和科学家 和塔夫茨大学。JHU试验研究小组Bios将在业务上召开这次会议 组织并提供工作人员执行所需的统计和安全资源中心 计划及其在统计、安全和dsmb领域分配的具体任务 管理层。我们的联合专业知识，开发和管理这些特定领域的试验 这些领域远远超出了过去三年关于正在进行的治愈疼痛ERN的工作 我们小组作为临床协调中心和数据进行的研究 在不同的NIH IC为数十个大型多中心临床试验协调中心。 我们将与我们在犹他州杜克大学和范德比尔特大学的合作伙伴一起，支持获奖者 以同样协作和全面的方式进行新的镰状细胞试验的团队 这一点已经在正在进行的五项审判中得到证明，目前这些审判是 治愈疼痛ERN倡议。

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.