Johns Hopkins-Tufts Trial Innovation Center

约翰·霍普金斯-塔夫茨试验创新中心

• 批准号: 9309120
• 负责人: DANIEL F HANLEY
• 金额: $ 547.05万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9309120
• 关键词: Administrator; Aging; Alzheimer' s Disease; Biological Markers; Clinical Research; Clinical Trials; Collaborations; Data Collection; Data Quality; Dementia; Disease; Education; Effectiveness; Enrollment; Ensure; Evaluation; Geriatrics; Goals; Grant; Healthcare; Individual; Institutes; Intervention; Joints; Lead; Learning; Link; Massachusetts; Measures; Methods; Mission; Multi-Institutional Clinical Trial; Multicenter Trials; Neurosciences; Pathway interactions; Patients; Performance; Process; Protocol Compliance; Protocols documentation; Publications; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Research; Research Institute; Research Personnel; Resources; Sampling; Science; Scientist; Services; Site; Speed; Technology; Testing; Time; Translational Research; Translations; Universities; Validity of Results; advanced system; clinical practice; design; dissemination trial; effectiveness trial; experience; follow-up; improved; innovation; multi-site trial; multidisciplinary; novel; novel strategies; operation; performance site; process optimization; programs; service utilization; tool; trial design; virtual; working group

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.

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））。JHU试验研究小组BIOS将在运作上召集该小组，并提供工作人员来执行所需的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，从而将卓越的TIC试验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氏症及其他痴呆症试验执行方面的成就和创新，这将有助于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项目试验更好的方案合规性，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。