Innovative Approaches to Randomized Behavioral Clinical Trials

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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.