Johns Hopkins-Tufts Trial Innovation Center

JHU-Tufts试验创新中心（TIC）是一个由多中心试验PI、经验丰富的主要经理、管理员和科学家组成的成熟的职能团队，他们来自约翰霍普金斯大学（JHU）和塔夫茨大学（包括其长期合作伙伴哈佛临床研究所（HCRI）和马萨诸塞州理工学院（MIT））。BIOS是JHU的一个试验研究小组，将在运作上召集该小组，并提供工作人员执行所需的TIC计划及其具体任务。我们共同开发多中心试验新方法的专业知识将提供给TIC项目，从而将个别TIC试验的卓越和创新纳入后续试验。该提案源于我们在神经科学和阿尔茨海默病以及其他痴呆症试验执行成就和创新方面的既定记录，这将促进NCATS实现生产三个强大的TIC以加速转化研究的目标。我们将制定、演示和传播一个综合、协调、多利益相关方的TIC流程，以提高多中心试验启动和随后由研究中心执行的效率和质量。JHU-Tufts TIC将利用老年医学、衰老疾病和阿尔茨海默病方面的运营服务专业知识，进行CTSA试验，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项目试验更高的方案依从性，并适用于阿尔茨海默病、生物标志物研究（淀粉样蛋白Aβ、tau蛋白、皮质厚度）和其他衰老试验。我们将使用明确的效率和以质量为中心的指标来衡量效益，以测试这些创新。我们将向当前的临床试验团队和研究学员传播所有联盟试验产生的有效CTSA-TIC创新成果。我们希望与NCATS合作，建立一个平台，使研究人员能够更快、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 disease 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 disease, biomarker studies (amyloid Aβ, tau, cortical thickness) 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.