Johns Hopkins University Trial Innovation Center

约翰霍普金斯大学(JHU)试验创新中心(TIC)是一支久负盛名、高度运转的团队 其目标是显著提高多点随机对照试验的进行、效率和影响。 TIC包括经验丰富的试验科学家、项目经理、统计学家和外部试验工作人员 来自5个研究密集型CTSA中心的合作者。JHU试验研究小组BIOS将开始运作 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，并 其具体任务如前所述，由TICS、RICS和NCATS协作确定。在我们的TIN 1.0期间 联合专家开发和演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点随机试验的个人CTSA Hub PI。这项建议是 源自我们在审判执行成就和审判科学创新方面的既定记录， 将促进这些方法和具体试验工具的传播，以加快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：中心工作人员的试训、 运营而不是战略，Hub CCC/DCC能力的指导，以及对最新信息的需求 操作方法/工具。在TIN 2.0中，我们将进一步开发新的测试工具和方法来测试它们的易用性 在CTSA中心的实施情况，展示这一方法的有效性，并广泛传播到 CTSA中心，使用案例研究和教学方法。我们提出了一个综合的、协调的、多方利益相关者的TIC 提高CTSA站点多站点试验启动和后续执行的效率和质量的流程。 我们的外部合作者小组将作为更大的CTSA-TIN财团的样本来开发Hub 在整个案件和整个联合体的基础上执行和传播办法。JHU TIC将 利用CTSA试验实施中的运营活动，研究可改进的新运营创新 参与者参与度、干预依从性和试验终点的测量。我们将衡量收益 使用明确的以效率和质量为重点的指标来测试这些创新。我们的科学目的是 团队的努力将是证明TIC在试验设计、执行和评估方面的创新可以导致 更好的试用性能，包括更快的启动、更快的完成、更高的协议合规性等 精确的终端。我们将传播联盟试验产生的经过验证的CTSA-TIN创新的结果 CTSA Hub临床试验团队和研究实习生。我们将与NCATS合作利用该平台 在TIN 1.0中展示了通过CTSA聘用和装备多站点随机临床试验工作人员 在TIN 2.0中以更快和更高质量执行试验的中心。

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.