Innovative Approaches to Randomized Behavioral Clinical Trials

项目总结 这个高级的短期课程将提供关于随机行为的创新方法的强化培训 临床试验。该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、健康 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 测试与健康相关的行为干预措施的有效性、有效性和成本效益的科学； 和c)传播课程材料，并利用这些材料培训其他研究人员 接近了。每年的36名参与者中的大多数(四年内有144名)将是职业生涯中期的科学家，但 该课程将向所有学术级别和各种与健康相关的学科开放。12名核心教员 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、生物统计学方法。他们还将有两个人加入 兼职教员和几位特邀演讲者。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指导机会。本课程将针对 每天不同的目标，每天的目标将遵循与 创新的、以战略为重点的行为干预研究计划的演变。该序列 从确定与健康相关的行为研究的长期战略目标开始，取得了进展 通过第一阶段和第二阶段，并以最终的第三阶段试验和对第四阶段研究的介绍结束。天 1将讨论反向翻译战略以及医疗保健看门人和利益攸关方在 制定战略研究目标。第2天从设定目标开始，确定哪种行为 因素和临床结果要达到目标，才能实现研究计划的目标。第3天介绍 可用于结构化干预研究的翻译研究模型和优化框架 方案，并加快取得更好结果的进展。它还涵盖了构建多样化、 包容性、跨学科的研究团队和多中心网络。头三天奠定了基础 在接下来的五天课程中，在第一阶段的一系列高级方法学主题中， II和III的干预研究将包括在内。课程的最后一天将包括对 跨学科团队项目，讨论学员传播课程材料的计划，以及 讨论学员计划将他们在课程中学到的知识融入自己的研究中 程序。将收集多层次的评估数据，并用于完善下一年的计划。 开放访问最佳讲座和小组讨论的视频记录和PowerPoint文件，以及 文章和附带的教育项目，将确保课程的可持续性。

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.