Inter-disciplinary Program for Training and Mentoring in CER Methods and Practice

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DESCRIPTION (provided by applicant): Because Comparative Effectiveness Research (CER) relies on broad assessments of complex healthcare issues, appropriate methods and applications are paramount. The ability to obtain, evaluate, interpret, and effectively disseminate evidence must necessarily integrate understanding of the medical problems under study with appropriate analytic strategies. To meet these challenges, CER training requires an approach that includes investigators and mentors who speak the various methodological and clinical languages of CER, building from a common experience. Hence, we propose an interdisciplinary CER KM1 training program, focused on Biostatistics, Cancer, and Cardiology that matches mentors from diverse CER methodological backgrounds with mentees committed to a career in CER. A leadership team of experienced Duke CE researchers will organize, catalyze and perpetuate this effort. This application proposes a "team science" approach, emphasizing statistical methodology, medical insight, and cross-discipline communication. We have created a methods hub in the Department of Biostatistics and Bioinformatics (B&B), with close ties to two major disease areas: cancer and cardiology. Didactic training in both existing and developing curricula will be available to Scholars, who will also gain experience in two dynamic high-volume clinical areas that each are substantially impacted by CER activities. The KM1 program is structured so that each Scholar will benefit from the following: " Mentoring team: An individualized mentoring team that will include at least two senior leaders: a clinician researcher with expertise in CER and a PhD methodologist (typically, a biostatistician) with expertise that matches the proposed research program. " Education: Formal didactic training in CER or targeted coursework, with several options, including coursework in the Duke Clinical Research Training Program (CRTP) and Duke Masters in Biostatistics. "Research experience: A primary research project and up to one secondary project, approved by the mentor, the PIs, and an internal advisory committee, to be completed within the timeframe. Projects will be designed to achieve academic recognition as well as have meaningful impact on healthcare. "Academic career development: Enrollment in Duke's new CTSA-supported faculty career skills program for K-awardees, incorporating grantsmanship, public speaking, manuscript writing, negotiating, navigating the institutional research landscape, and keys to successful mentoring. We anticipate that each scholar will devote 50% effort to the KM1 for a period of two years in order to achieve maximum benefit from the research and didactic experiences, as well as recently established resources available to trainees at Duke. Four scholars will be recruited in the first year of the program and six in the second. By the end of the third year of the program, ten Duke CER KM1 Scholars will have completed a research project, prepared accompanying manuscripts, and developed an independent grant. Further, our Scholars will be part of a larger team of investigators and institutional leaders, readying them for a productive, collaborative career. Our immediate objectives are to recruit the initial classes of Scholars, focusing first on biostatistics, cancer and cardiology, and to provide them with a top-flight educational experience in CER. As our capacity and capabilities expand, we look forward to adding new therapeutic areas to the portfolio of Scholars. In addition to a variety of ongoing research projects available to scholars, new courses focusing on CER are being developed in the B&B Department and new training modules have been instituted in the Duke CTSA. Duke's resources, mentors, and commitment to CER will give our CER KM1 Scholars a truly outstanding opportunity for a rich learning experience and long-term career path. At an institutional level, our long-term objective is to foster the training and growth of the next generation of the nation's leading clinical and outcomes researchers. At a programmatic level, our long-term objective is to use the KM1 program to help expand and more explicitly coordinate our efforts in mentoring and faculty development as they pertain to CER. We now have the infrastructure, the ability, and the desire to refine our training programs to support a unique cohort of Scholars who will become the future leaders in CER that will make a difference in healthcare. PUBLIC HEALTH RELEVANCE: There are many steps between initial evidence that some therapy might be effective in treating a certain disease and the final assessment of how effective it actually is, which patients are likely to benefit from it, whether the benefits outweigh the risks, and whether it can be implemented into clinical practice in a cost- effective manner. All of these steps require researchers who understand the underlying issues, can frame the appropriate questions, and know the right methods for obtaining answers. The goal of this training grant is to expand the number of researchers who have this type of expertise.