Johns Hopkins Statistical and Safety Resource Center-HEAL PAIN ERN

摘要 JHU-Tufts TIC是一个由多中心试验PI组成的成熟且有效的团队，经验丰富 约翰霍普金斯大学（JHU）的主要管理人员、行政人员和科学家 和塔夫茨大学BIOS，JHU试验研究小组，将在运作上召集这次会议。 组织并提供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领域的具体分配任务 管理我们的联合专业知识，开发和管理这些特定领域的试验 领域远远超出了过去三年的工作正在进行的愈合疼痛ERN 我们的研究小组作为临床协调中心和数据中心， 在各个NIH IC的数十个大型多中心临床试验的协调中心。 我们将与杜克大学、犹他州大学和范德比尔特大学的合作伙伴一起，为获奖者提供支持 以同样的协作和全面的方式， 这一点已在目前作为联合国国际刑事法院判决的一部分而进行的五项审判中得到证明。 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.