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.

项目摘要 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 改善临床试验设计和影响的解决方案。在我们的UM 1临床和 2023年5月1日开始的转化科学奖，我们将举办两个设计实验室，并制定一个剧本， 提供材料和培训，以支持这一方法的传播。与之前由塔夫茨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 补编将以案例为基础，重点是制定创新方法，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， 临床试验提案将由设计实验室团队进行评分和仔细选择。的 成功的用例将是那些其考虑也将提供可推广信息的用例 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，这些会议将帮助研究人员团队 考虑相关利益相关者提出的试验;确保他们对设计进行创新性思考 选项和机会;并磨练他们想要带到设计实验室活动的问题。的 这一过程的高潮是一个活动，该活动将来自世界各地的各种利益相关者聚集在一起， 该方案涵盖了生物医学领域，并对该提案采取了系统一级的办法，重点是健康影响。一份报告 是在活动结束后制作的，用于总结研究小组当天的主题和学习成果。 除了试验的具体报告，这将是保密的，塔夫茨设计实验室团队将与 研究小组和TIN传播更广泛的，可推广的学习创新设计 方法论设计实验室的工作计划将继续发展与输入和支持，从三角网， 以创新的方式瞄准临床试验的障碍，并从基于案例的例子中学习， 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。

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.