Tufts Clinical and Translational Science Institute (Clinical Trial Design Labs Supplement)

项目摘要 塔夫茨临床试验设计实验室是结构化的多方利益相关者活动，支持创新的 改善临床试验设计和影响的解决方案。在我们UM1临床和医疗服务的第一年 翻译科学奖将于2023年5月1日开始，我们将主办两个设计实验室，并制定 支持传播这一方法的材料和培训。与之前由Tuft领导的设计实验室一样 约翰·霍普金斯-塔夫茨试验创新中心(JHU-塔夫斯TIC)的一部分，设计实验室将在此基础上完成 补充部分将以案例为基础，重点发展创新的方法来改进设计 并实施临床试验。我们将与试验创新网络(TIN)合作，发出呼吁 设计实验室团队将对临床试验提案进行评分和精心挑选。这个 成功的用例将是那些考虑还将提供概括性信息的用例 关于创新的临床试验设计。 设计实验室流程以一系列详细和互动的会议开始：帮助调查团队 考虑他们提议的试验的相关利益相关者；确保他们对设计进行创造性的思考 选择和机会；并磨练他们想要带到设计实验室活动中的问题。这个 这一过程以一次活动结束，该活动汇聚了来自 生物医学领域，并对该提案采取系统层面的方法，重点是对健康的影响。一份报告 是活动结束后制作的，为研究团队总结当天的主题和学习。 除了保密的试验具体报告外，塔夫茨设计实验室团队还将与 研究团队和TIN传播关于创新设计的更广泛、可推广的知识 方法论。设计实验室的工作计划将在TIN的投入和支持下继续发展， 以创新的方式针对临床试验障碍，并从基于病例的例子中学习 与相关利益攸关方一起讨论如何在翻译领域取得科学进展。

Project Summary Tufts Clinical Trial Design Labs are structured multi-stakeholder events that support development of innovative solutions to improve the design and impact of clinical trials. During the first year of our UM1 Clinical and Translational Science Award that starts May 1, 2023, we will host two Design Labs and develop a playbook of materials and training to support the dissemination of this approach. As with prior Design Labs led by the Tufts part of the Johns Hopkins-Tufts Trial Innovation Center (JHU-Tufts TIC), the Design Labs to be done under this supplement will be case-based and focused on development of innovative methodology to improve the design and implementation of clinical trials. We will work with the Trial Innovation Network (TIN) to put out a call for proposals, and the clinical trial proposals will be scored and carefully selected by the Design Lab team. The use cases that are successful will be those whose consideration will also provide generalizable information about innovative clinical trial designs. The Design Lab process begins with a series of detailed and interactive meetings that: help investigator teams consider the relevant stakeholders for their proposed trial; ensure that they think innovatively about the design options and opportunities; and hone the questions that they want to bring to the Design Lab event. The process culminates with an event that brings together a diverse group of stakeholders from across the biomedical spectrum and takes a systems-level approach to the proposal, focusing on health impact. A report is produced after the event to summarize themes and learnings from the day for the study team. In addition to the trial specific report, which will be confidential, the Tufts Design Lab team will work with the investigator team and the TIN to disseminate broader, generalizable learnings about innovative design methodology. The Design Lab program of work will continue to evolve with input and support from the TIN, targeting clinical trial roadblocks in innovative ways, and learning from case-based examples that bring together relevant stakeholders to discuss how to make scientific progress across the translational spectrum.