Johns Hopkins University Trial Innovation Center

约翰霍普金斯大学试验创新中心

• 批准号: 10651047
• 负责人: DANIEL F HANLEY
• 金额: $ 497.28万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-05 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10651047
• 关键词: Adherence; Case Study; Clinical; Clinical Trials; Clinical and Translational Science Awards; Collaborations; Communities; Consensus; Consultations; Data; Dissemination and Implementation; Educational Curriculum; Effectiveness; Enrollment; Evaluation; Funding; Goals; Human Resources; Individual; Informatics; Intervention; Joints; Laboratories; Lead; Link; Measurement; Measures; Methods; Mission; Multi-Institutional Clinical Trial; Multicenter Trials; Multiple Partners; National Center for Advancing Translational Sciences; Needs Assessment; Outcome; Patients; Performance; Preceptorship; Principal Investigator; Process; Production; Protocol Compliance; Protocols documentation; Randomized, Controlled Trials; Research; Sampling; Science; Scientist; Services; Site; Speed; Testing; Time; Training; Translational Research; Universities; Validation; Visit; Work; data quality; effectiveness evaluation; evidence base; experience; follow-up; improved; innovation; multi-site trial; novel; operation; patient engagement; performance site; program dissemination; programs; randomized trial; randomized, clinical trials; recruit; service delivery; timeline; tool; trial design; trial planning; uptake

The Johns Hopkins University (JHU) Trial Innovation Center (TIC) is a well-established, highly functioning team with a goal of dramatically improving the conduct, efficiency and impact of multisite randomized controlled trials. The TIC includes experienced trial scientists, project managers, statisticians, and trial staff with external collaborators from 5 research intensive CTSA Hubs. BIOS, a JHU trials research group, will operationally convene this group and provide staff to execute version 2.0 of the Trial Innovation Network (TIN) program and its specific tasks as previously and collaboratively determined by the TICs, RICs and NCATS. During TIN 1.0 our joint expertise Developed and Demonstrated new methods for multicenter trials and provided these methods via the TIN platform to individual CTSA Hub PIs wishing to perform multisite randomized trials. This proposal is derived from our established track record of trial execution accomplishments and trial science innovations, which will facilitate dissemination of these methods and specific trial tools towards the NCATS goal to speed translational research. We identified needs not met in TIN 1.0 including: trial training of hub staff, training in operations rather than strategy, preceptorship for Hub CCC/DCC capabilities, and need for up-to-date operational methods/tools. In TIN 2.0 we will further Develop new trial tools and methods for testing their ease of implementation at CTSA hubs, Demonstrate the effectiveness of this approach, and Disseminate broadly to CTSA Hubs, by using case studies and didactics. We propose an integrated, coordinated, multi-stakeholder TIC process to improve the efficiency and quality of multi-site trial initiation and subsequent execution by CTSA sites. Our group of external collaborators will work as a sample of the larger CTSA-TIN consortium to develop Hub implementation and dissemination approaches on both a case- and consortium-wide basis. The JHU TIC will leverage operational activities in CTSA trials implementation to study novel operational innovations that improve participant engagement, intervention adherence and measurement of trial endpoints. We will measure benefits using explicit efficiency- and quality-focused metrics to test these innovations. The scientific purpose of our team’s efforts will be to demonstrate that TIC innovations in trial design, execution, and evaluation can lead to better trial performance, including faster start-up, faster completion, greater protocol compliance and more precise endpoints. We will disseminate results of validated CTSA-TIN innovations produced from consortia trials to CTSA Hub clinical trial teams and research trainees. We will collaborate with NCATS to utilize the platform demonstrated in TIN 1.0 to engage and equip a multisite randomized clinical trial workforce through the CTSA Hubs to perform trials faster and at a higher quality in TIN 2.0.

约翰·霍普金斯大学（JHU）试验创新中心（TIC）是一支成就良好，功能齐全的团队 旨在显着改善多站点随机对照试验的行为，效率和影响。 该节目包括经验丰富的审判科学家，项目经理，统计学家和外部的审判人员 来自5个研究密集CTSA枢纽的合作者。 JHU试验研究小组BIOS将进行操作 便利这个小组，并为员工提供执行试用创新网络（TIN）计划的2.0版和 它的特定任务如前及由TICS，RICS和NCATS确定。在锡1.0期间 共同开发并展示了用于多中心试验的新方法，并通过 希望执行多站点随机试验的单个CTSA HUB PI的TIN平台。该提议是 来自我们既定的审判执行收购和试用科学创新的记录， 将有助于传播这些方法和针对NCAT的特定试验工具，以加快速度 翻译研究。我们确定了TIN 1.0中未满足的需求，包括：枢纽工作人员的试用培训，培训 操作而不是策略，用于HUB CCC/DCC功能的录音，并且需要最新 操作方法/工具。在TIN 2.0中，我们将进一步开发新的试验工具和方法来测试其易于 在CTSA枢纽实施，证明了这种方法的有效性，并广泛传播到 CTSA轮毂，使用案例研究和教学用法。我们提出了一个综合，协调的，多方利益相关者的抽搐 提高多站点试验计划的效率和质量的过程以及CTSA站点随后执行的过程。 我们的外部合作者小组将作为较大CTSA-TIN联盟的样本来开发集线器 在案例和财团范围内采用实施和传播方法。 Jhu Tic将 利用CTSA试验实施中的运营活动，以研究改善的新型运营创新 参与者参与，干预依从性和试验终点的测量。我们将衡量利益 使用明确的效率和质量指标来测试这些创新。我们的科学目的 团队的努力是证明试验设计，执行和评估方面的抽动创新可能会导致 更好的试用性能，包括更快的启动，更快完成，更大的协议合规性等等 精确端点。我们将传播通过财团试验产生的经过验证的CTSA-TIN创新的结果 到CTSA中心临床试验团队和研究受训者。我们将与NCAT合作利用平台 在TIN 1.0中证明，通过CTSA参与和配备了多站点随机临床试验劳动力 枢纽在TIN 2.0中进行试验更快，质量更高。