Johns Hopkins-Tufts Trial Innovation Center

JHU-Tufts试验创新中心（TIC）代表了一个由多中心试验PI组成的成熟的功能团队， 约翰霍普金斯大学（JHU）和塔夫茨大学（Tufts）经验丰富的首席经理、行政人员和科学家 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， 该小组并提供工作人员执行所需的TIC计划及其具体任务。我们的共同专长 为多中心试验开发新方法将提供给TIC项目， 将在随后的试验中采用卓越和创新的方法执行。这一提议源自 从我们既定的审判执行成就和创新的跟踪记录，这将有助于 NCATS的目标是生产三个强大的TIC，以加快转化研究的进展。我们将 制定、展示和传播一个综合、协调、多方利益相关者的TIC流程， 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 在CTSA试验实施中利用运营服务，研究新的运营创新。的 我们团队努力的科学目的将是证明TIC在试验设计，执行， 和评估将导致更好的试验性能，包括更快的启动，更快的完成， 方案依从性。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， 这些创新。我们将传播联盟试验产生的有效CTSA-TIC创新成果， 目前的临床试验团队和研究实习生。我们希望与NCATS合作， 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) represents 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 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, multi-stakeholder 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 in 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. 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 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.