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

描述（由申请人提供）：由于比较有效性研究（CER）依赖于对复杂医疗保健问题的广泛评估，适当的方法和应用是至关重要的。获取、评估、解释和有效传播证据的能力必须将对所研究的医学问题的理解与适当的分析策略结合起来。为了应对这些挑战，CER培训需要一种方法，包括从共同经验的基础上，使用各种CER方法和临床语言的研究人员和导师。因此，我们提出了一个跨学科的CER KM1培训计划，重点是生物统计学，癌症和心脏病学，将来自不同CER方法背景的导师与致力于CER职业生涯的学员相匹配。由经验丰富的杜克大学CE研究人员组成的领导团队将组织、促进和延续这一努力。该应用程序提出了一种“团队科学”方法，强调统计方法，医学洞察力和跨学科沟通。我们在生物统计和生物信息部（B&B）建立了一个方法中心，与两个主要疾病领域：癌症和心脏病学密切相关。学者们将获得现有课程和开发课程的教学培训，他们还将获得两个动态的高容量临床领域的经验，这两个领域都受到CER活动的重大影响。KM1计划的结构使每位学者都能从以下方面受益：“指导团队：一个个性化的指导团队，将包括至少两名高级领导：一名具有CER专业知识的临床研究员和一名具有与拟议研究计划相匹配的专业知识的博士方法学家（通常是生物统计学家）。”教育：CER的正式教学培训或有针对性的课程，有几种选择，包括杜克大学临床研究培训计划（CRTP）和杜克大学生物统计学硕士课程。研究经验：一个主要研究项目和最多一个次要研究项目，由导师、项目总监和内部咨询委员会批准，并在规定时间内完成。项目的设计既要获得学术认可，又要对医疗保健产生有意义的影响。学术生涯发展：杜克大学新推出的ctsa支持的k奖获得者教师职业技能项目，包括资助、公开演讲、手稿写作、谈判、引导机构研究景观，以及成功指导的关键。我们预计每位学者将在两年的时间里为KM1投入50%的精力，以便从研究和教学经验中获得最大的收益，以及杜克大学新近建立的可供学员使用的资源。该项目第一年将招收4名学者，第二年将招收6名。到项目第三年结束时，10名杜克大学CER KM1学者将完成一个研究项目，准备相关手稿，并获得独立资助。此外，我们的学者将成为一个更大的研究人员和机构领导团队的一部分，为他们的富有成效的合作事业做好准备。我们的近期目标是招募首批学者，首先关注生物统计学、癌症和心脏病学，并为他们提供在CER的一流教育体验。随着我们的能力和能力的扩大，我们期待在学者的投资组合中增加新的治疗领域。除了为学者提供的各种正在进行的研究项目外，B&B部门正在开发以CER为重点的新课程，杜克大学CTSA也建立了新的培训模块。杜克大学的资源，导师和对CER的承诺将为我们的CER KM1学者提供丰富的学习经验和长期职业发展道路的真正出色的机会。在机构层面，我们的长期目标是促进下一代国家领先的临床和结果研究人员的培训和成长。在计划层面上，我们的长期目标是利用KM1项目来帮助扩大和更明确地协调我们在指导和教师发展方面的努力，因为它们与CER有关。我们现在有基础设施、能力和愿望来完善我们的培训项目，以支持一批独特的学者，他们将成为CER未来的领导者，在医疗保健领域发挥作用。

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.