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

塔夫茨临床和转化科学研究所（临床试验设计实验室补充材料）

• 批准号: 10844980
• 负责人: Harry P. Selker
• 金额: $ 97.51万
• 依托单位: TUFTS UNIVERSITY BOSTON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2030-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10844980
• 关键词: Address; Area; Biomedical Research; Case Based Learning; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Design; Clinical and Translational Science Awards; Development; Discipline; Education; Ensure; Environment; Event; Face; Fostering; Funding; Grant; Health; Individual; Leadership; Learning; Maps; Measures; Mentors; Methodology; Parents; Population Heterogeneity; Process; Public Health; Reporting; Research; Research Design; Research Personnel; Resource Sharing; Resources; Role; Running; Science; Series; Services; Structure; System; Time; Training; Translating; Translation Process; Translational Research; Translations; Treatment Efficacy; Work; Writing; case-based; clinical trial implementation; design; evidence base; experience; flexibility; health equity promotion; implementation framework; improved; innovation; insight; interest; meetings; process improvement; programs; response; safety testing; therapy development; translational pipeline

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.

项目概要 塔夫茨临床试验设计实验室是结构化的多利益相关者活动，支持创新的开发 改善临床试验设计和影响的解决方案。在我们 UM1 临床的第一年 转化科学奖将于 2023 年 5 月 1 日开始，我们将举办两个设计实验室并开发一本剧本 支持传播这种方法的材料和培训。与之前由塔夫茨大学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-Tufts TIC) 的一部分，设计实验室将在此下完成 补充材料将以案例为基础，重点关注开发创新方法以改进设计 和临床试验的实施。我们将与试验创新网络 (TIN) 合作，呼吁 方案，临床试验方案将由设计实验室团队进行评分和精心挑选。这 成功的用例将是那些考虑因素也能提供通用信息的用例 关于创新的临床试验设计。 设计实验室流程从一系列详细的互动会议开始：帮助研究团队 考虑相关利益相关者的拟议试验；确保他们对设计进行创新思考 选择和机会；并磨练他们想要在设计实验室活动中提出的问题。这 整个过程的高潮是一场将来自不同领域的利益相关者聚集在一起的活动 生物医学领域，并对该提案采取系统级方法，重点关注健康影响。一份报告 活动结束后制作，为研究团队总结当天的主题和经验教训。 除了保密的具体试验报告外，塔夫茨设计实验室团队还将与 研究人员团队和 TIN 传播有关创新设计的更广泛、通用的知识 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， 以创新方式瞄准临床试验障碍，并从基于案例的例子中学习 与相关利益相关者一起讨论如何在转化领域取得科学进展。

项目成果

Incomplete Data and Potential Risks of Drugs in People with Obesity.

• DOI: 10.1007/s13679-023-00532-1
• 发表时间: 2023-12
• 期刊: CURRENT OBESITY REPORTS
• 影响因子: 8.8
• 作者: Apovian, Caroline M.;Bruno, Christopher D.;Kyle, Theodore K.;Chow, Christina R.;Greenblatt, David J.
• 通讯作者: Greenblatt, David J.