Johns Hopkins Statistical and Safety Resource Center-HEAL PAIN ERN

约翰霍普金斯大学统计和安全资源中心-HEAL PAIN ERN

• 批准号: 10709636
• 负责人: DANIEL F HANLEY
• 金额: $ 181.27万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-23 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10709636
• 关键词: Administrator; Area; Award; Clinical; Clinical Trials; Collaborations; Data; Data Coordinating Center; Helping to End Addiction Long-term; Infrastructure; Joints; Lead; Leadership; Multi-Institutional Clinical Trial; National Center for Advancing Translational Sciences; Opioid; Pain; Pain management; Protocols documentation; Public Health; Research; Resources; Safety; Scientist; Sickle Cell; Specific qualifier value; Speed; United States National Institutes of Health; Universities; Utah; Work; design; effectiveness research; experience; innovation; multi-site trial; programs; recruit; statistics

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.

抽象的 Jhu-tufts TIC是一个成熟的多站点试验的团队，经验丰富 约翰·霍普金斯大学（JHU）的首席经理，管理人员和科学家 和塔夫茨大学。 JHU试验研究小组BIOS将在操作中汇总此事 分组并提供员工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领域的特定指定任务 管理。我们的共同专业知识，开发和管理这些规定的试验 领域范围远远超出了过去三年的持续治疗疼痛的工作 与我们小组的研究是临床协调中心和数据 在各种NIH IC的数十个大型多中心临床试验中协调中心。 我们将与我们在杜克，犹他州和范德比尔特的合作伙伴一起支持获奖者 新的镰状细胞试验的团队以相同的协作和全面的方式进行 目前正在进行的五项审判中，这已被证明 治愈疼痛主管。