Core-004

核心004

• 批准号: 10198073
• 负责人: David H Ellison
• 金额: $ 70.08万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-02 至 2022-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10198073
• 关键词: Achievement; Area; Biometry; Clinical Research; Complex; Consultations; Data Analyses; Development; Ensure; Fostering; Funding; Goals; Health; Infrastructure; Institution; Intervention; Knowledge; Measures; Methodology; Mission; Oregon; Process; Reporting; Research Design; Research Ethics; Research Institute; Research Methodology; Resource Sharing; Services; System; Time; Training; Translating; Translational Research; Universities; design; epidemiology study; experience; flexibility; human subject protection; improved; innovation; programs; success

The Research Methods section comprises two components focused on planning, operationalizing, and implementing high quality Clinical and Translational Research (CTR) at OHSU and partnering institutions: Biostatistics, Epidemiology and Research Design (BERD), and Regulatory Knowledge and support (RKS). In OCTRI 2.0, each of these components has well-articulated goals, accompanied by relevant specific aims to accomplish those goals. All the Research Methods aims are well aligned with the overarching aims for OCTRI; contributions for each of the modules toward achievement of those aims will be measured and evaluated. Both components capitalize on achievements in the prior OCTRI funding cycles, and leverage activities of successful units that are essential to the OHSU infrastructure (in particular the Biostatistics & Design Program [BDP] and the Office of Clinical Research), to ensure efficient and timely progress toward goals. In recent years, great strides have been made tackling CTR challenges; however, the studies of complex systems requires innovative methodologies and processes to effectively and efficiently translate discoveries into interventions to improve health. Indispensable to the success of CTR are considerations in the areas of research ethics, study design, data analyses, and interpretation. Thus, Cores dedicated to planning, operationalizing, and implementing high quality CTR at OHSU are essential for achieving the overarching goals of OCTRI 2.0. Responding to the challenges put forth in the IOM report to drive innovation in CTR, OCTRI’s Biostatistics, Epidemiology and Research Design component (OCTRI-BERD) proposes initiatives aimed at fostering methodology development, providing flexible personalized training experiences, and promoting professional development of BERD practitioners. In addition, OCTRI-BERD will further enhance the provision of collaborative and consultative services offered through our Biostatistics University Shared Resource, Biostatistics & Design Program. The Regulatory Knowledge and Support component proposes initiatives aimed at delivery of regulatory consultations services, training the workforce in human subjects’ protections, and alleviating regulatory-related bottlenecks in CTR. These efforts will further OCTRI’s missions and catalyze CTR regionally and throughout the CTSA network.

研究方法部分包括两个部分，重点是规划，操作， 在OHSU和合作机构实施高质量的临床和转化研究（CTR）： 生物统计学，流行病学和研究设计（BERD），以及监管知识和支持（RKS）。在 在OCTRI 2.0中，每个组件都有明确的目标，并附有相关的具体目标， 实现这些目标。所有的研究方法目标都与OCTRI的总体目标保持一致; 将衡量和评价每个单元对实现这些目标的贡献。两 各组成部分利用OCTRI之前资助周期的成就，并利用 对OHSU基础设施至关重要的成功单位（特别是生物统计与设计计划 [BDP]和临床研究办公室），以确保有效和及时地实现目标。 近年来，在解决CTR挑战方面取得了很大进展;然而， 系统需要创新的方法和流程，以有效和高效地转化发现 来改善健康状况。合作减少损失的成功离不开以下方面的考虑： 研究伦理、研究设计、数据分析和解释。因此，核心致力于规划， 在OHSU实施和实施高质量的CTR对于实现总体目标至关重要。 OCTRI 2.0的目标。为应对IOM报告中提出的推动合作减少风险创新的挑战， OCTRI的生物统计学、流行病学和研究设计部分（OCTRI-BERD）提出了一些倡议， 旨在促进方法的发展，提供灵活的个性化培训体验， 促进BERD从业人员的专业发展。此外，OCTRI-BERD还将进一步提高 通过我们的生物统计学大学提供的合作和咨询服务的提供共享 资源，生物统计学和设计程序。监管知识和支持部分建议 旨在提供监管咨询服务的举措，在人类受试者方面培训劳动力， 保护，并缓解CTR中与监管相关的瓶颈。这些努力将进一步促进OCTRI的使命 并在区域和整个CTSA网络中催化CTR。