Biostatistics, Epidemiology, and Research Design Core

方法和统计支持方面的重大差距破坏了科学严谨的行为 和文化响应的临床和转化研究(CTR)，特别是在翻译阶段T3到 T5。为了填补这些空白，生物统计学、流行病学和研究设计(BERD)的核心将包括七个 不同的组成部分：生物统计学、流行病学、研究设计、数据科学、心理测量学、混合 方法和经济分析。Berd Core的目标将是提供资源并加强技能 初级调查员(JI)和老牌调查员过渡到CTR，进行精心设计的CTR 减少影响太平洋土著人民(IPP)的健康差距，IPP被定义为夏威夷原住民 其他太平洋岛民、菲律宾人和夏威夷其他医疗服务不足和脆弱的人群。 具体目标1：为设计和分析健康差距CTR提供定制服务 通过利用现有资源和实施 招募适当人员、宣传资源并协助用户的有效运营计划； 协助调查人员获取适当的有效数据；支持调查人员开发 全面、高质量、不偏不倚、高效、可靠和符合文化要求的研究设计，包括 解决方法上的偏见；优先支持IPP健康差距CTR，特别是 疗效试验(T3)和有效性试验(T4)以及收养和制度化试验(T5)。 具体目标2：通过以下方式提供关于健康差距CTR方法的教育和培训 指导联检组/执行机构使用适合CTR的BERD工具和方法；通过促进和促进 有利于职业提升的环境，强调立功准备和提交 联检组/EI提出的研究建议，特别是那些具有IPP血统的建议；通过设计和促进一项学术-- 关于研究方法和过程的参与方案；并通过创建和促进新的外联 提供研究设计、数据分析和沟通方面的支持、指导和教育的计划 社区合作伙伴。 具体目标3：开发工具和方法，通过以下方式最大限度地提高健康差距CTR的质量 建立/整合对CTR至关重要的研究设计和生物统计学；通过创建设计和分析 对独特、服务不足或弱势群体的研究计划；通过推进设计和分析计划 用于少数参与者的研究；以及开发创新方法以增强统计能力。 到5年结束时，BERD核心将推动初级调查人员和其他人员的CTR职业生涯 过渡调查人员，特别是具有IPP背景的调查人员，支持他们确保联邦 提供资金进行独立研究，旨在改善IPP和其他未得到充分服务和 夏威夷的弱势群体。

Substantial gaps in methodological and statistical support undermine the conduct of scientifically rigorous and culturally responsive clinical and translational research (CTR), especially at the translational Stage T3 to T5. To fill these gaps, the Biostatistics, Epidemiology, and Research Design (BERD) Core will feature seven distinct components: Biostatistics, Epidemiology, Research Design, Data Science, Psychometrics, Mixed Methods, and Economic Analysis. BERD Core’s objective will be to provide resources and strengthen the skills of junior investigators (JI) and established investigators transitioning to CTR in conducting well-designed CTR that reduce the health disparities affecting Indigenous Pacific Peoples (IPP), defined as Native Hawaiians, Other Pacific Islanders, Filipinos, and other medically underserved and vulnerable populations in Hawaii. Specific Aim 1: Provide customized services for the design and analysis of health-disparities CTR by optimizing the use of BERD Core services through leveraging of existing resources and implementing an effective operational plan that recruits appropriate personnel, publicizes resources, and assists users; by assisting investigators in capturing appropriate valid data; by supporting investigators in developing comprehensive, high-quality, unbiased, efficient, reliable, and culturally responsive study designs, including those that address bias in methodology; and by prioritizing support for IPP health-disparities CTR, particularly trials of efficacy (T3) and effectiveness (T4) and adoption and institutionalization (T5). Specific Aim 2: Provide education and training on health-disparities CTR methodologies by mentoring JI/EI in the use of BERD tools and methods appropriate to CTR; by fostering and facilitating environments conducive to career enhancement, emphasizing the preparation and submission of meritorious research proposals by JI/EI, especially those of IPP descent; by designing and promoting an academic- engagement program on research methods and processes; and by creating and promoting a novel outreach program to provide support, mentoring, and education on study design, data analysis, and communication to community partners. Specific Aim 3: Develop tools and methods that maximize the quality of health-disparities CTR by establishing/integrating research designs and biostatistics essential to CTR; by creating design and analysis plans for studies of unique, underserved, or vulnerable populations; by advancing design and analysis plans for studies of small numbers of participants; and developing innovative methods to enhance statistical power. By the end of 5 years, the BERD Core will advance the CTR careers of junior investigators and other transitioning investigators, especially those with IPP backgrounds by supporting their efforts to secure federal funding to conduct independent research aimed at improving the health of IPP and other underserved and vulnerable populations in Hawaii.