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.

在更大的学习范围内协调临床和转化研究(CTR)方法和CTSA联盟 卫生系统可以推动研究并改进对卫生保健信息的利用，以促进知识和 改进实践。要做到这一点，CTR必须依赖一系列复杂的方法，从新的研究设计到 高维数据分析、因果推理、中介分析和贝叶斯推理方法。 由于方法论研究是CTR的一个关键方面，因此吸引最好的统计学家和 流行病学家接受CTR，并培养他们的职业发展。了解相关法规和 驾驭道德和合规环境的能力对CTR也是至关重要的。过去的几年里 监管框架发生了重大变化，从NIH的数据共享要求到21世纪 治疗法、病人“试用权”立法和2018年对共同规则条例的修订。我们的 建议的研究方法包括生物统计学、流行病学和 研究设计(BERD)和道德、监管知识和支持(ERKS)核心。这些是必不可少的 核心领导至关重要的活动，以支持临床和翻译中心的目标 科学与培训(CCTST)。BERD和ERK在CCTST中高度整合，他们的目标是 与整个CCTST的情况保持一致。为了吸引利益相关者，BERD核心将提供专家 与有价值的项目进行磋商和重点合作，积极为BERD做出贡献并领导BERD CTSA联合体中的社区。ERKS核心将建立一个道德中心，涵盖所有 并加强知情同意程序。促进劳动力发展和 多样性，BERD核心将培养CTR方法学家社区，培养BERD教师和 员工发展，并在研究设计、数据方面教育和培训临床和翻译研究人员 管理和数据分析。ERKS核心将提供培训和教育，并促进道德和 专业发展方面的监管知识。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 促进新方法和新流程的开发和推广。ERKS核心将设计和 实施研究启动程序，促进单一机构审查委员会(IRB)的审查和 适应修订后的共同规则中的其他变化。