Johns Hopkins-Tufts Trial Innovation Center

约翰·霍普金斯-塔夫茨试验创新中心

基本信息

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
项目类别：
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&apos 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

项目摘要

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）是约翰·霍普金斯大学（JHU）和TUFTS大学（包括其长期以来的长期合作伙伴，哈佛大学临床研究所（HCRI）（HCRI）和马萨诸塞州科技研究所（Massachusetts Institute of Technology）（Massachusets Institute of Technology），Johns Hopkins University（JHU）和Tufts University的多站长PIS，经验丰富的首席经理，管理人员和科学家组成的职能团队。 JHU试验研究小组BIOS将操作该小组，并为员工提供执行所需的TIC计划及其特定任务。我们的联合专家开发了用于多中心试验的新方法，将向TIC计划提供，在该计划中，将以卓越的卓越和创新来执行单个TIC试验，并纳入随后的试验中。该提案源自我们既定的神经科学，阿尔茨海默氏症和其他痴呆症审判执行成就和创新的记录，这将有助于。朝着NCAT的目标迈进了三种强大的抽动以加快转化研究的目标。我们将开发，演示和传播一个集成的，协调的，多利益相关者的TIC流程，以提高多站点试验计划的效率和质量，并随后通过网站执行。 Jhu-tufts TIC将利用老年医学，衰老疾病和阿尔茨海默氏病的运营服务专家进行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是证明试验设计，执行和评估方面的TIC创新将导致更好的试验性能，包括更快的启动，更快的完成以及所有NCATS计划试验的协议合规性，并适用于阿尔茨海默氏症和其他老年人试验。我们将使用明确的效率和以质量为中心的指标来衡量收益，以测试这些创新。我们将传播从所有当代试验到当前临床试验团队和研究受训者的有效CTSA-TIC创新的结果。我们希望与NCAT合作生产一个平台，使调查人员能够更快地进行试验。