Johns Hopkins-Tufts Trial Innovation Center

JHU-Tufts试验创新中心（TIC）是一个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、经验丰富的首席管理人员、管理人员和科学家组成的成熟、有效的团队。JHU试验研究小组BIOS将负责召集该小组，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，从而使单个TIC试验能够以卓越和创新的方式执行，并纳入后续试验。该提案源于我们在神经科学、阿尔茨海默病和其他痴呆症试验执行方面的成就和创新，这将促进NCATS目标的进展，即产生三个强大的tic以加速转化研究。我们将发展、示范和推广一个综合、协调、多利益相关方参与的TIC流程，以提高多地点试验启动和随后由地点执行的效率和质量。JHU-Tufts TIC将利用老年病、老年疾病和阿尔茨海默病方面的运营服务专业知识进行CTSA试验实施，以研究新的运营创新。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项目试验更大的协议遵从性，并适用于阿尔茨海默病和其他衰老试验。我们将使用明确的效率和以质量为中心的指标来衡量这些创新的效益。我们将把所有联合试验中产生的有效的CTSA-TIC创新结果传播给当前的临床试验团队和研究学员。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 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.