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:

临床和转化研究缺乏足够的高质量、可重复的数据， 这是有效转化基础研究以改善健康成果的主要障碍。这一复杂问题 包括研究设计不足，研究结果传播效率低下，患者招募不足， 电子健康实践的次优使用，以及糟糕的文档实践。大约三分之二的典型 误差与实验设计和操作中的问题有关。适当的研究设计包括 全面的计划、绩效、文档、分析和发布方法。研究 UTMB的方法专家在综合研究设计和统计分析中发挥着关键作用， 解释和传播高质量、符合伦理的临床和转化研究。We have experience 在整个转化研究连续体，在生物信息学，以病人为中心， 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， 网络分析。在本研究方法部分，我们将解决临床和 翻译研究使我们的CTSA更有效，更高效，使我们的研究更容易传播 来改善全国的健康状况为了做到这一点，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。生物统计流行病学与研究设计 小组将为研究人员提供方便的生物统计教育/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、严谨性和效率。的 临床研究办公室将为研究者和研究团队提供重点监管知识， 临床试验管理支持。我们将通过开发应用程序等创新工具为调查人员提供支持 评估数据质量和数据挖掘方法，以评估药物治疗相关毒性。我们还将 应用创新技术来加强试验设计和分析比较有效性的结果 research.此外，我们还将开发一个获得电子同意的流程。我们的研究方法部分将提高临床和转化研究的创新、可及性和质量。 在UTMB的研究。这是通过研究方法、中心容量和 信息学.我们的研究方法程序包括两个集成模块。生物统计学，流行病学 和研究设计（BERD）团队是UTMB转化研究使命的重要组成部分， 提供：研究设计和生物统计学方面的团队合作和咨询;继续教育， 指导和培训的学生和教师;和强大的支持，以信息学的核心。BERD将继续 在UTMB开发创新研究方法方面发挥关键作用，特别强调增强 临床试验、先进的比较有效性研究方法和新颖的数据管理工具。的 临床研究办公室（OCR）成立于2011年6月，是研究服务部门之间的联合倡议 和CTSA它是一个多学科的服务组织，由一个在申办的临床方面经验丰富的团队组成。 研究，支持教师与赞助的临床试验和制药商发起的临床研究项目。 在我们创新记分卡的持续改进模型的指导下， 研究方法部分将解决以下具体目标：