Innovative Approaches to Randomized Behavioral Clinical Trials

随机行为临床试验的创新方法

• 批准号: 10334476
• 负责人: KENNETH E FREEDLAND
• 金额: $ 21.57万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10334476
• 关键词: Address; Administrator; Behavior Therapy; Behavioral; Behavioral Research; Biostatistical Methods; Clinical; Clinical Practice Guideline; Clinical Trials; Clinical Trials Design; Data; Discipline; Doctor of Philosophy; Educational workshop; Effectiveness; Ensure; Evaluation; Evolution; Faculty; Formulation; Gatekeeping; Goals; Guidelines; Health; Healthcare; Healthcare Systems; Individual; Institution; Interdisciplinary Study; Intervention Studies; Mentorship; Methodology; Modeling; Outcome; Participant; Persons; Phase; Phase II/III Trial; Play; Policies; Prevention Guidelines; Prevention program; Public Health; Randomized; Research; Research Methodology; Research Personnel; Research Project Grants; Research Training; Role; Science; Scientist; Senior Scientist; Site; Slide; Structure; Technology; Trainers Training; Training; Translational Research; Update; Video Recording; behavioral clinical trial; career; cost effectiveness; design; efficacy testing; evidence base; experience; health care cost/financing; health care service; health goals; improved; improved outcome; innovation; interest; learning materials; lectures; member; phase 4 study; phase III trial; prevention service; process repeatability; programs; translational approach

PROJECT SUMMARY This advanced short course will provide intensive training in innovative approaches to randomized behavioral clinical trials. The long-term goal of the course is to increase the clinical impact and public health significance of health-related behavioral intervention research. It will achieve this goal by training the participants to a) identify ways to maximize the impact of their research on clinical practice and prevention guidelines, health care financing policies, and health care services; b) utilize advanced methodologies and interdisciplinary team science to test the efficacy, effectiveness, and cost-effectiveness of health-related behavioral interventions; and c) disseminate the course materials and use them to train other researchers in these advanced approaches. A majority of the 36 participants each year (144 over four years) will be mid-career scientists but the course will be open to all academic ranks and to a variety of health-related disciplines. The 12 core faculty members are experts and experienced educators in various aspects of behavioral intervention research methodology, clinical trial design and management, and biostatistical methods. They will be joined by two adjunct faculty members and several guest speakers. The 8½ day course will feature lectures, panel discussions, interdisciplinary team projects, and individual mentorship opportunities. The course will address a different objective each day, and the daily objectives will follow a coherent sequence that corresponds to the evolution of an innovative and strategically-focused behavioral intervention research program. The sequence starts with the identification of long-term, strategic goals for health-related behavioral research, progresses through Phases I and II, and ends with definitive Phase III trials and an introduction to Phase IV research. Day 1 will address reverse translation strategies and the key roles of health care gatekeepers and stakeholders in the formulation of strategic research goals. Day 2 moves from goal-setting to determine which behavioral factors and clinical outcomes to target in order to achieve the research program's goals. Day 3 covers the translational research models and optimization frameworks that can be used to structure intervention research programs and accelerate progress towards improved outcomes. It also covers approaches to building diverse, inclusive, interdisciplinary research teams and multicenter networks. The first three days lay the groundwork for the next five days of the course, during which a succession of advanced methodological topics in Phase I, II, and III intervention research will be covered. The final day of the course will include a presentation of the interdisciplinary team projects, discussion of participants' plans for dissemination of course materials, and discussion of participants' plans for incorporating what they have learned in the course into their own research programs. Multi-level evaluation data will be collected and used to refine the program for the following year. Open access to video recordings and PowerPoint files of the best lectures and panel discussions, as well as articles and spin-off educational programs, will ensure the sustainability of the course.

项目摘要 这个先进的短期课程将提供密集的培训，在创新的方法，以随机行为 临床试验课程的长期目标是增加临床影响和公共卫生意义 与健康相关的行为干预研究。它将通过培训参与者来实现这一目标： 确定如何最大限度地发挥其研究对临床实践和预防指南的影响， 保健筹资政策和保健服务; B）利用先进的方法和跨学科团队 科学测试与健康有关的行为干预措施的功效、有效性和成本效益; c）传播课程材料，并利用这些材料培训其他研究人员， 接近。每年36名参与者中的大多数（四年144人）将是职业生涯中期的科学家， 课程将开放予所有学术职级及多个与卫生有关的学科参加。12核心教师 成员是行为干预研究各个方面的专家和经验丰富的教育工作者 方法学、临床试验设计和管理以及生物统计学方法。他们将加入两个 助理教师和几位客座演讲者。为期8天半的课程将包括讲座，小组讨论， 讨论、跨学科团队项目和个人导师机会。本课程将针对 不同的目标，每天的目标将遵循一个连贯的序列，对应于 一个创新的和战略重点的行为干预研究计划的演变。序列 从确定与健康相关的行为研究的长期战略目标开始， 通过第一阶段和第二阶段，并最终确定第三阶段试验和介绍第四阶段研究。天 1将解决反向翻译策略和卫生保健守门人和利益相关者的关键作用， 制定战略研究目标。第二天，从设定目标，以确定哪些行为 因素和临床结果，以实现研究计划的目标。第三天涵盖了 可用于构建干预研究的转化研究模型和优化框架 计划和加快进展，以改善成果。它还涵盖了建立多样化， 具有包容性的跨学科研究团队和多中心网络。头三天是打基础的 在接下来的五天的课程中，在第一阶段中， II和III干预研究将被覆盖。课程的最后一天将包括介绍 跨学科团队项目，讨论学员的课程材料传播计划，以及 讨论参与者计划将他们在课程中学到的知识融入他们自己的研究 程序.将收集多层次的评估数据，并用于改进下一年的方案。 开放获取最佳讲座和小组讨论的视频记录和PowerPoint文件，以及 文章和衍生教育计划，将确保课程的可持续性。