Core-004

核心004

• 批准号: 10414771
• 负责人: RONALD J. SOKOL
• 金额: $ 87.76万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-01 至 2023-11-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10414771
• 关键词: Address; Biometry; Clinic; Clinical; Clinical Research; Colorado; Competence; Complex; Computer software; Data Analyses; Development; Ecosystem; Ensure; Environment; Ethics; Evaluation; Face; Goals; Informatics; Information Dissemination; Infrastructure; Institutes; Institution; Knowledge; Leadership; Longevity; Measures; Methodology; Methods; Outcome; Participant; Phase; Process; Reproducibility; Research; Research Design; Research Methodology; Research Personnel; Resources; Science; Site; System; Tin; Training; Translational Research; community based participatory research; community engagement; design; education resources; epidemiology study; improved; innovation; member; multidisciplinary; novel; programs; software development; tool; translational barrier

The Research Methods Program is constructed to support with innovative solutions the design, analysis, ethics, and regulatory challenges that face clinical and translational research (CTR) teams in the complex ecosystem in which CTR research is now conducted. The Research Methods Program is comprised of two Cores: 1) the Biostatistics, Epidemiology and Research Design (BERD) core and 2) the Regulatory Knowledge and Support (RKS) core. This program will build upon, share leadership with and collaborate with the corresponding campus-wide infrastructure programs, extending the reach and impact of the CCTSI by leveraging other campus resources to transform our CTR research enterprise. BERD and RKS programs will have co-created activities (Aim 1) that will form a seamless resource for new study design and start-up support for our investigators. The BERD and RKS programs have also identified specific barriers to translation and will develop solutions for removing these barriers, demonstrate the efficacy of these new solutions and disseminate our best practices both within our institution and to the CTSA Consortium (Aims 2-5). The Research Methods goals will be achieved through the following Specific Aims: Aim 1: Develop a multidisciplinary Study Jump-Start Clinic to improve the design and analysis rigor and ensure that ethics and regulatory aspects are responsibly addressed in clinical and translational research. Aim 2: Develop and disseminate new Methodologies for data analysis including development of new software. Aim 3: Develop and promote innovative training and educational resources to encourage rigorous and reproducible designs and analyses in clinical and translational research. Aim 4: Promote an efficient, responsible and safe research environment across the lifespan of each study and facilitate improvements in the research enterprise to promote: Efficiency, Quality, and Ethics. Aim 5: Develop, adapt and disseminate innovative research tools using a regulatory science framework to promote competency. Innovative aspects of this program are an efficient approach to getting investigators together with critical team members prior to submitting a proposal for review, a software development team to enhance analysis methods dissemination, a novel research results dissemination tool kit focused on improving the rate at which study teams provide study results to participants. In addition, BERD and RKS, as our Research Methods Program, will facilitate interactions with the Informatics, Ethics, Community Engagement & Research (CE&R) and TIN Liaison Team to assist investigators in optimal use of these resources. The overall result will be an efficient system to enhance research design and analysis and to accelerate the efficiency of the design-to-implementation phase of the translational research process. Successful completion of the aims will transform the clinical and translational landscape, improve the research rigor, and create innovative solutions to design, analysis and regulatory challenges in clinical and translational research. These outcomes will be measured by the Evaluation Core using the Common Metrics and site specific metrics.

研究方法计划旨在通过创新的解决方案来支持设计，分析，道德， 临床和转化研究（CTR）团队在复杂的生态系统中面临的监管挑战 目前正在进行CTR研究。研究方法计划由两个核心组成：1） 生物统计学，流行病学和研究设计（BERD）核心和2）监管知识和 支持（RKS）核心。该计划将建立在，分享领导，并与相应的合作 校园范围内的基础设施计划，通过利用其他校园来扩大CCTSI的覆盖范围和影响力 资源来改造我们的CTR研究企业。BERD和RKS计划将共同创建活动 (Aim 1）这将为我们的研究者提供新研究设计和启动支持的无缝资源。的 BERD和RKS项目还确定了翻译的具体障碍，并将制定解决方案， 消除这些障碍，展示这些新解决方案的有效性，并传播我们的最佳实践 在我们的机构和CTSA联盟（目标2-5）。研究方法的目标将实现 通过以下具体目标：目标1：发展多学科研究启动诊所，以改善 设计和分析的严谨性，并确保在临床中负责任地解决伦理和监管问题 和翻译研究。目标2：开发和传播新的数据分析方法，包括 开发新软件。目标3：开发和促进创新培训和教育资源， 鼓励在临床和转化研究中进行严格和可重复的设计和分析。目标4：促进 在每项研究的整个生命周期内提供高效、负责任和安全的研究环境，并促进 研究企业的改进，以促进：效率，质量和道德。目标5：发展、适应和 利用监管科学框架传播创新研究工具，以提高能力。创新 该计划的各个方面是将调查人员与关键团队成员聚集在一起的有效方法 在提交提案供审查之前，一个软件开发小组将加强分析方法 传播，一个新的研究成果传播工具包，重点是提高研究团队 向参与者提供研究结果。此外，BERD和RKS，作为我们的研究方法计划，将 促进与信息学、道德、社区参与和研究（CE&R）以及TIN联络员的互动 协助调查人员最佳利用这些资源的小组。总体结果将是一个有效的系统， 加强研究设计和分析，加快设计到实施阶段的效率 翻译研究的过程。这些目标的成功实现将改变临床和 翻译景观，提高研究的严谨性，并创造创新的解决方案，设计，分析和 临床和转化研究中的监管挑战。这些成果将由评价小组进行衡量。 核心使用通用数据库和站点特定指标。