Clinical Research Design, Epidemiology, and Biostatistics Core

摘要-临床研究设计、流行病学和生物统计学核心 采用稳健的研究设计，结合现代统计学和流行病学方法，在以下方面发挥了重要作用 整合的多学科研究团队，旨在优化新技术开发的途径 实验室中的治疗方法、技术和设备应用于改进诊断、治疗和 预防病人的疾病。我们建议开展临床研究设计、流行病学和 生物统计学是国际扶轮--CCTS的关键组成部分，旨在提供专业知识和资源，以促进 机构边界，将增加当代的能力、成熟度和应用 罗德岛临床和转化性研究的分析方法。关键组件将 连接分散在布朗大学阿尔伯特医学院和其 七家附属医院，布朗公共卫生学院和罗德岛大学药学院。 目前这些实体之间的协作依赖于临时分析团队，这些团队不进行交互和研究 没有统一核心的设计指导。因此，方法的专业知识未能达到广泛的临床应用 观众，现有的团队没有从其他人的经验中受益，新的方法和工具也没有 分布广泛。我们的目标是建立一个中央“店面”，调查人员可以通过它访问所有 全州可用的研究工具和来自其著名学术附属机构的研究培训。在……里面 为了制定这一计划，我们提出了以下三个具体目标： 具体目标1：服务和资源：开发一个易于访问的多学科综合中心， 为临床和翻译研究人员提供研究设计以及收集、管理、 使用程序分析、解释和介绍数据，确保质量控制和 所有分析的重复性 具体目标2：教育和指导：编写和提供研究设计、流行病学方面的培训材料 以及为职业生涯初期和中期的研究人员提供统计协作和生物统计方面的培训 为核心统计工作人员和学生顾问提供咨询 具体目标3：工具和方法开发：提供支持环境以支持临床 调查人员和统计分析员开发、验证和传播创新设计和分析 临床和翻译研究问题引发的方法学问题 拟议的关键组成部分将通过创建 普遍获得关键的专门知识、工具和资源。这一访问将接触到年轻的调查人员， 在与世隔绝的环境中获得飞行员奖和临床医生。它将培训年轻的方法学家进行研究合作 并为年轻人和老年人提供更广泛的问题，以开发和测试创新的解决方案。

ABSTRACT – CLINICAL RESEARCH DESIGN, EPIDEMIOLOGY AND BIOSTATISTICS CORE Use of robust study design with modern statistical and epidemiologic methods plays an essential role in integrated, multidisciplinary research teams created to optimize the pathway from the development of new treatments, techniques and devices in the laboratory to their application for improved diagnosis, treatment, and prevention of disease of patients. We propose to develop the Clinical Research Design, Epidemiology, and Biostatistics Key Component of the RI-CCTS to provide expertise and resources to facilitate research across institutional boundaries that will increase the capacity, sophistication, and application of contemporary analytical approaches to transform clinical and translational research in Rhode Island. The Key Component will connect strong but isolated research units scattered throughout Brown University Alpert Medical School and its seven affiliated hospitals, Brown School of Public Health and University of Rhode Island College of Pharmacy. Current collaboration among these entities has relied on ad hoc analytic teams that do not interface and study design mentoring with no unified core. As a result, methods expertise has failed to reach a broad clinical audience, existing teams have not benefited from others' experience and new methods and tools are not widely distributed. We aim to create a central “storefront” through which investigators could access all of the research tools available throughout the state and research training from its renowned academic affiliates. In order to develop this program, we propose the following three Specific Aims: Specific Aim 1: Services & Resources: Develop an easily accessible multidisciplinary, integrated center that provides support to clinical and translational investigators in study design as well as collection, management, analysis, interpretation and presentation of data using procedures that ensure quality control and reproducibility of all analyses Specific Aim 2: Education & Mentoring: Develop and offer training materials in study design, epidemiology and biostatistics for early and mid-career investigators as well as provide training in statistical collaboration and consultation for core statistical staff and student consultants Specific Aim 3: Tools & Method Development: Provide a supportive environment to enable clinical investigators and statistical analysts to develop, validate and disseminate innovative design and analytical methodology arising from clinical and translational research problems The proposed Key Component will transform clinical and translational research in Rhode Island by creating universal access to critical expertise, tools and resources. This access will reach young investigators receiving Pilot Awards and clinicians in isolated environments. It will train young methodologists in research collaboration and provide young and old with a wider range of problems on which to develop and test innovative solutions.