Johns Hopkins-Tufts Trial Innovation Center HEAL Pain ERN Supplement

受资助父母奖摘要 JHU-Tuft试验创新中心(TIC)是一支成熟的、运作良好的团队 多站点试验PI、经验丰富的主管经理、管理员和科学家 约翰霍普金斯大学(JHU)和塔夫茨大学(包括其历史悠久的 合作伙伴，哈佛临床研究所(HCRI)和麻省理工学院 理工学院(MIT))。JHU试验研究小组Bios将在业务上召开这次会议 组织并提供员工来执行所需的TIC计划及其具体任务。我们的 将向旅游业议会提供联合专门知识，开发多中心试验的新方法 将以卓越和创新的方式执行TIC个人试验计划 纳入了随后的试验。这项建议是从我们既定的轨道衍生出来的 神经科学和阿尔茨海默氏症及其他痴呆症试验执行记录 成就和创新，这将促进在NCATS方面取得进展 目标是产生三个健壮的TICE来加速翻译研究。我们将发展， 展示和传播一个综合、协调、多方利益相关者的TIC 提高多点试验启动和后续试验的效率和质量的过程 按地点执行。JHU-Tuft TIC将利用运营服务专业知识 实施CTSA试验的老年病、老年病和阿尔茨海默病 研究新的运营创新。我们团队努力的科学目的将是 证明TIC在试验设计、执行和评估方面的创新将导致 更好的试用性能，包括更快的启动、更快的完成和更好的协议 符合所有NCATS计划试验，并适用于阿尔茨海默氏症和其他 老化试验。我们将使用明确的效率和以质量为重点来衡量收益 测试这些创新的指标。我们将公布有效的CTSA-TIC结果 从所有联盟试验到当前临床试验团队和研究产生的创新 实习生。我们希望与NCATS合作制作一个平台，允许 调查人员以更快的速度和更高的质量进行试验。

ABSTRACT OF THE FUNDED PARENT AWARD The JHU-Tufts Trial Innovation Center (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 (including its longstanding partners, the Harvard Clinical Research Institute (HCRI) and Massachusetts Institute of Technology (MIT)). BIOS, a JHU trials research group, will operationally convene this group and provide staff to execute the required TIC program and its specific tasks. Our joint expertise, developing new methods for multicenter trials, will be provided to the TIC program whereby individual TIC trials will be executed with excellence and innovations incorporated into subsequent trials. This proposal is derived from our established track record of neuroscience and Alzheimer’s and other dementia trial execution accomplishments and innovations, which will facilitate progress towards the NCATS goal of producing three robust TICs to speed translational research. We will Develop, Demonstrate, and Disseminate an integrated, coordinated, multistakeholder TIC process to improve the efficiency and quality of multi-site trial initiation and subsequent execution by sites. The JHU-Tufts TIC will leverage operational service expertise in geriatrics, diseases of aging and Alzheimer’s disease for CTSA trials implementation to study novel operational innovations. The scientific purpose of our team’s efforts will be to demonstrate that TIC innovations in trial design, execution, and evaluation will lead to better trial performance, including faster start-up, faster completion, and greater protocol compliance for all NCATS program trials and be applicable to Alzheimer’s and other aging trials. We will measure benefits using explicit efficiency and quality-focused metrics to test these innovations. We will disseminate results of valid CTSA-TIC innovations produced from all consortia trials to current clinical trial teams and research trainees. We hope to collaborate with NCATS to produce a platform that allows investigators to perform trials faster and at a higher quality.