Project-004

项目-004

• 批准号: 10376313
• 负责人: Randall J Urban
• 金额: $ 51.62万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-18 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10376313
• 关键词: Address; Area; Basic Science; Bioinformatics; Biometry; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical and Translational Science Awards; Collaborations; Comparative Effectiveness Research; Complex; Consultations; Country; Data; Databases; Documentation; Education; Ethics; Experimental Designs; Faculty; Health; Informatics; Joints; Knowledge; Mentors; Methods; Mission; Modeling; Outcome; Pathway Analysis; Patient Recruitments; Patient-Focused Outcomes; Performance; Pharmacotherapy; Play; Process; Publications; Reproducibility; Research; Research Design; Research Methodology; Research Personnel; Research Project Grants; Resources; Role; Services; Statistical Data Interpretation; Students; Techniques; Toxic effect; Training; Training and Education; Translational Research; Translations; base; data management; data mining; data quality; electronic consent; epidemiology study; experience; faculty support; improved; innovation; multidisciplinary; novel; programs; service organization; tool; translational study; trial design

The lack of sufficient high-quality, reproducible data across clinical and translational research is creating a major obstacle for the effective translation of basic research to improve health outcomes. This complex problem includes inadequate study design, inefficient dissemination of research findings, inadequate patient recruitment, suboptimal use of electronic health practices, and poor documentation practices. About two thirds of typical errors are related to problems in the experimental design and performance. Proper study design involves a comprehensive approach to planning, performance, documentation, analysis, and publication. The research methods experts at UTMB play a critical role in comprehensive study design and statistical analysis, as well as interpretation and dissemination of high-quality, ethical clinical and translational research. We have experience across the entire translational research continuum, with particular expertise in bioinformatics, patient-centered outcomes research/comparative effectiveness research, large database analysis, clinical trials, data mining, and network analysis. In this research methods component we will address the major issues in clinical and translational studies making our CTSA more effective, efficient, and making our studies easily disseminated to improve health across the country. To accomplish this, we will provide resources to our investigators in the areas Biostatistics, Epidemiology and Research Design. The Biostatistics Epidemiology and Research Design group will provide researchers easy access to biostatistical education/training, research design consultation, and innovative tools and methods to enhance the quality, rigor and efficiency of clinical and translational. The Office of Clinical Research will provide investigators and study teams with focused regulatory knowledge and clinical trial management support. We will support investigators with innovative tools such as developing apps to assess data quality and data mining methods to assess pharmacotherapy-associated toxicities. We will also apply innovative techniques to enhance trial design and to analyze the results of comparative effectiveness research. In addition, we will develop a process to obtain electronic consent.Our Research Methods component will enhance innovation, access and quality of clinical and translational research at UTMB. This is accomplished with tight integration between research methods, hub capacity, and informatics. Our research methods program encompasses two integrated modules. The Biostatistics, Epidemiology and Research Design (BERD) team is an essential component of the translational research mission at UTMB, providing: team-based collaboration and consultation on research design and biostatistics; continuous education, mentoring and training to students and faculty; and strong support to the informatics core. BERD will continue to play a critical role in developing innovative research methods at UTMB, with particular emphasis on enhanced clinical trials, advanced comparative effectiveness research methods, and novel data management tools. The Office of Clinical Research (OCR) was established in June 2011 as a joint initiative between Research Services and the CTSA. It is a multidisciplinary service organization, staffed by a team experienced in sponsored clinical research, that supports faculty with sponsored clinical trials and investigator-initiated clinical research projects. Guided by the continuous improvement model of our Innovation Score Card, the integrated modules of our Research Methods component will address the following Specific Aims:

临床和转化性研究中缺乏足够的高质量、可重复的数据正在创造一种 有效地将基础研究转化为改善健康成果的主要障碍。这个复杂的问题 包括研究设计不充分，研究结果传播效率低下，患者招募不足， 电子保健做法的非最佳使用，以及糟糕的文档做法。约三分之二的典型 错误与实验设计和性能中的问题有关。正确的研究设计包括 全面的规划、执行、文档、分析和发布方法。这项研究 方法UTMB的专家在综合研究设计和统计分析中发挥关键作用 解释和传播高质量、符合伦理道德的临床和翻译研究。我们有经验 在整个转译研究连续体中，以患者为中心，在生物信息学方面拥有特别的专业知识 结果研究/比较有效性研究、大型数据库分析、临床试验、数据挖掘、 和网络分析。在本研究方法部分，我们将解决临床和临床中的主要问题 翻译研究使我们的CTSA更有效、更高效，并使我们的研究更容易传播 以改善全国的健康状况。为了实现这一目标，我们将向我们的调查人员提供资源 生物统计学、流行病学和研究设计领域。生物统计学、流行病学与研究设计 集团将为研究人员提供轻松的生物统计学教育/培训、研究设计咨询、 以及创新的工具和方法，以提高临床和翻译的质量、严谨和效率。这个 临床研究办公室将为研究人员和研究团队提供集中的监管知识和 临床试验管理支持。我们将为调查人员提供创新工具，如开发应用程序 评估数据质量和评估药物治疗相关毒性的数据挖掘方法。我们还将 应用创新技术加强试验设计并分析比较效果结果 研究。此外，我们将开发一个获得电子同意的流程。我们的研究方法组件将促进临床和翻译的创新、准入和质量 在UTMB进行研究。这是通过研究方法、枢纽能力和 信息学。我们的研究方法课程包括两个集成模块。生物统计学、流行病学 和研究设计(BERD)团队是UTMB翻译研究任务的重要组成部分， 提供：研究设计和生物统计方面的团队协作和咨询；继续教育， 对学生和教职员工的指导和培训；以及对信息学核心的大力支持。伯德将继续 在开发UTMB创新研究方法方面发挥关键作用，特别强调加强 临床试验、先进的比较有效性研究方法和新的数据管理工具。这个 临床研究办公室(OCR)成立于2011年6月，是由研究服务部门 和CTSA。它是一个多学科的服务组织，由一支在赞助临床方面经验丰富的团队组成。 研究，通过赞助临床试验和研究人员发起的临床研究项目为教师提供支持。 在创新记分卡的持续改进模式指导下，我们的集成模块 研究方法部分将涉及以下具体目标：