Johns Hopkins-Tufts Trial Innovation Center

JHU-Tuft试验创新中心(TIC)代表了一支成熟的、运作良好的多点试验PI团队， 约翰·霍普金斯大学(JHU)和塔夫茨大学(Tuft)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、哈佛临床研究所和 麻省理工学院(MIT))。JHU试验研究小组BIOS将召开业务会议 该小组并提供工作人员执行所需的TIC计划及其具体任务。我们的联合专业知识 将向TIC方案提供开发多中心试验的新方法，从而进行单独的TIC试验 将以卓越的表现执行，并在随后的试验中纳入创新。这项建议是根据 从我们已建立的审判执行成就和创新记录中，这将有助于 朝着NCATS的目标取得进展，即产生三个健壮的TIC以加速翻译研究。我们会 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，以改进 多站点试验启动和后续站点执行的效率和质量。JHU-Tuft TIC将 利用CTSA试验实施中的运营服务来研究新的运营创新。这个 我们团队努力的科学目的将是证明TIC在试验设计、执行、 评估将带来更好的试用性能，包括更快的启动、更快的完成和更大的 协议合规性。我们将使用明确的效率和以质量为重点的指标来衡量好处以进行测试 这些创新。我们将把财团试验产生的有效CTSA-TIC创新的结果传播给 目前的临床试验团队和研究实习生。我们希望与NCATS合作制作一个平台 这使得调查人员能够更快、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.