Johns Hopkins-Tufts Trial Innovation Center

JHU-塔夫茨试验创新中心(TIC)是由约翰霍普金斯大学(JHU)和塔夫茨大学(包括其长期合作伙伴哈佛临床研究所(HCRI)和麻省理工学院(MIT))的多站点试验PI、经验丰富的首席经理、管理人员和科学家组成的成熟的运作团队。JHU试验研究小组BIOS将在业务上召集该小组，并提供工作人员执行所需的TIC计划及其具体任务。我们开发多中心试验新方法的联合专业知识将被提供给TIC计划，根据该计划，单个TIC试验将以卓越的表现执行，并将创新纳入后续试验。这一建议源于我们在神经科学、阿尔茨海默氏症和其他痴呆症试验执行方面取得的成就和创新，这将促进朝着NCATS的目标取得进展，即产生三个健壮的抽搐以加快翻译研究。我们将制定、示范和传播一个综合的、协调的、多方利益相关者的TIC流程，以提高多站点试验启动和随后站点执行的效率和质量。JHU-Tuft TIC将利用老年病、老年病和阿尔茨海默病方面的运营服务专业知识，实施CTSA试验，研究新的运营创新。我们团队努力的科学目的是证明TIC在试验设计、执行和评估方面的创新将带来更好的试验性能，包括更快的启动、更快的完成，以及所有NCATS计划试验更好的协议遵从性，并适用于阿尔茨海默氏症和其他衰老试验。我们将使用明确的效率和以质量为重点的指标来衡量收益，以测试这些创新。我们将把所有联盟试验产生的有效CTSA-TIC创新的结果传播给当前的临床试验团队和研究受训人员。我们希望与NCATS合作，创造一个平台，让研究人员能够更快、更高质量地进行试验。

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.