Core-004

核心004

• 批准号: 10613559
• 负责人: JAMES E. HEUBI
• 金额: $ 50.61万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-14 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10613559
• 关键词: Bayesian Analysis; Biometry; Clinical; Clinical Research; Clinical Sciences; Collaborations; Communities; Complex; Consultations; Data; Data Analyses; Development; Epidemiologist; Epidemiology; Ethics; Fostering; Goals; Health system; Healthcare; Informed Consent; Institutional Review Boards; Knowledge; Lead; Learning; Mediation; Methods; Patient Rights; Procedures; Process; Regulation; Research; Research Design; Research Ethics; Research Methodology; Research Support; Staff Development; Statutes and Laws; Teacher Professional Development; Training; Training and Education; Translational Research; United States National Institutes of Health; Workforce Development; clinical center; common rule; data management; data sharing; design; improved; multidimensional data; translational scientist

Aligning Clinical and Translational Research (CTR) methods and the CTSA consortium within a larger Learning Health System can drive research and improve use of health care information to advance knowledge and improve practice. To do this, CTR must rely on a complex array of methods, ranging from new study designs to high-dimensional data analysis, causal inference, mediation analysis, and Bayesian inference methods. Because methodologic research is a key aspect of CTR, it is important to attract the best statisticians and epidemiologists to CTR, and to nurture their professional development. Knowledge of the regulations and the ability to navigate the ethical and compliance landscapes are also essential to CTR. The past few years have seen significant changes in the regulatory framework, from NIH data sharing mandates, to the 21st Century Cures Act, to patient “right to try” legislation and the 2018 revisions to the Common Rule regulations. Our proposed Research Methods encompass the aims and approaches of the Biostatistics, Epidemiology and Research Design (BERD) and Ethics, Regulatory Knowledge, and Support (ERKS) Cores. These essential cores lead critically important activities in support of the aims of the Center for Clinical and Translational Science and Training (CCTST). BERD and ERKS are highly integrated across the CCTST, and their goals align with those of the overall CCTST. To engage stakeholders, the BERD Core will provide expert consultation and focused collaboration with meritorious projects, and actively contribute to, and lead, the BERD community in the CTSA Consortium. The ERKS Core will build an Ethics Center that encompasses all stakeholders and enhances the informed consent process. To promote workforce development and diversity, the BERD Core will cultivate the community of CTR methodologists, fostering BERD faculty and staff development, and educate and train clinical and translational researchers in study design, data management, and data analysis. The ERKS Core will provide training and education and promote ethics and regulatory knowledge in professional development. To organize, integrate, and optimize data use, the BERD Core will provide expertise that supports research design, data management, and data analysis and promote the development and dissemination of new methods and processes. The ERKS Core will design and implement study startup procedures that facilitate single Institutional Review Board (IRB) review and accommodate other changes in the revised Common Rule.

在更大的学习中对齐临床和转化研究（CTR）方法和CTSA联盟 卫生系统可以推动研究并改善医疗保健信息的使用，以提高知识和 改善实践。为此，CTR必须依靠复杂的方法，从新研究设计到 高维数据分析，因果推断，中介分析和贝叶斯推断方法。 因为方法研究是CTR的关键方面，因此吸引最佳统计学家和 流行病学家对CTR，并为其专业发展提供护理。了解法规和 驾驶道德和合规性景观的能力对于CTR也是必不可少的。过去几年有 从NIH数据共享授权到21世纪，监管框架的重大变化 治疗法案，以供患者“尝试”立法和2018年对《共同规则法规》的修订。我们的 拟议的研究方法涵盖了生物统计学，流行病学和 研究设计（BERD）以及道德，监管知识和支持（ERK）核心。这些必不可少 核心领导着至关重要的活动，以支持临床和翻译中心的目标 科学与培训（CCTST）。 Berd和Erk在整个CCTST及其目标都高度融合 与整体CCTST保持一致。为了吸引利益相关者，BERD核心将为专家提供 咨询和专注于有功项目的合作，并积极地为BERD贡献和领导 CTSA财团的社区。 ERKS核心将建立一个涵盖所有的道德中心 利益相关者并增强知情同意程序。促进劳动力发展和 多样性，BERD核心将培养CTR方法学家的社区，促进Berd教师和 员工发展以及教育和培训临床和研究人员的研究人员，数据 管理和数据分析。 ERKS核心将提供培训和教育，并促进道德规范 专业发展中的监管知识。为了组织，集成和优化数据使用， Berd Core将提供支持研究设计，数据管理和数据分析的专业知识，并 促进新方法和过程的发展和传播。 Erks Core将设计和 实施研究启动程序，促进单机构审查委员会（IRB）审查和 适应修订后的共同规则中的其他变化。