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事件，可支持创新的发展 改善临床试验设计和影响的解决方案。在UM1临床的第一年和 从2023年5月1日开始的翻译科学奖，我们将主持两个设计实验室，并制定一本剧本 材料和培训以支持这种方法的传播。与先前的设计实验室一样 约翰·霍普金斯 - 塔夫茨试验创新中心（Jhu-tufts TIC）的一部分，设计实验室要在此下完成 补充剂将基于病例，并专注于开发创新方法以改善设计 和实施临床试验。我们将与试用创新网络（TIN）合作发出呼吁 建议和临床试验建议将由设计实验室团队评分和仔细选择。这 成功的用例将是那些考虑的考虑也将提供可推广的信息 关于创新的临床试验设计。 设计实验室流程始于一系列详细的互动会议：帮助调查员团队 考虑相关的利益相关者进行拟议的审判；确保他们对设计进行创新思考 选择和机会；并磨练他们想带给设计实验室活动的问题。这 流程最终达到了一项活动，该事件汇集了来自各地的各种利益相关者 生物医学光谱并采取系统级别的方法来解决该建议，重点是健康影响。报告 活动结束后生产，以总结研究团队的主题和学习。 除了特定的报告，这是机密的，塔夫茨设计实验室团队还将与 调查员团队和锡罐，以传播有关创新设计的更广泛，可概括的知识 方法论。设计实验室工作计划将继续随着锡的投入和支持而发展， 以创新的方式针对临床试验障碍，并从基于案例的示例中学习 相关的利益相关者共同讨论如何在翻译范围内取得科学进步。

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.