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）是一个完善的、高效的团队 其目标是显著改善多中心随机对照试验的实施、效率和影响。 TIC包括经验丰富的试验科学家、项目经理、统计学家和试验工作人员， 来自5个研究密集型CTSA中心的合作者。BIOS是JHU的一个试验研究小组， 召集该小组并提供工作人员执行试验创新网络（TIN）计划的2.0版， 其具体任务由技术信息中心、区域信息中心和国家技术援助中心先前共同确定。在TIN 1.0期间， 联合专家开发并展示了多中心试验的新方法，并通过以下方式提供这些方法： TIN平台提供给希望进行多中心随机试验的CTSA Hub PI。这项建议是 源于我们在审判执行成就和审判科学创新方面的既定记录， 将促进传播这些方法和具体的试验工具，以实现NCATS的目标， 翻译研究我们确定了TIN 1.0中未满足的需求，包括：中心工作人员的试验培训， 运营而不是战略，指挥中心CCC/DCC能力，以及需要最新的 操作方法/工具。在TIN 2.0中，我们将进一步开发新的试用工具和方法，以测试其易用性 在CTSA中心实施，证明这种方法的有效性，并广泛传播， CTSA中心，通过使用案例研究和教学法。我们建议建立一个综合、协调和多方利益相关者的议会 提高多中心试验启动和随后由CTSA中心执行的效率和质量的流程。 我们的外部合作者团队将作为更大的CTSA-TIN联盟的样本来开发Hub 在案例和整个联盟范围内的实施和传播方法。JHU TIC将 利用CTSA试验实施中的业务活动，研究新的业务创新， 参与者参与、干预依从性和试验终点测量。我们将衡量收益 使用明确的以效率和质量为中心的指标来测试这些创新。我们的科学目的 团队的努力将证明TIC在试验设计、执行和评估方面的创新可以导致 更好的试验性能，包括更快的启动、更快的完成、更好的方案依从性等 精确的终点。我们将传播联盟试验产生的经验证的CTSA-TIN创新成果 CTSA Hub临床试验团队和研究学员。我们将与NCATS合作利用该平台 在TIN 1.0中证明，通过CTSA吸引和配备多中心随机临床试验工作人员 在TIN 2.0中，集线器可以更快地执行试验，并具有更高的质量。