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:

临床和转化研究中缺乏足够的高质量，可重复的数据正在创造 有效翻译基础研究以改善健康结果的主要障碍。这个复杂的问题 包括研究设计不足，研究结果的效率低下，患者招募不足， 次优的电子健康实践和文档惯例不良。大约三分之二的典型 错误与实验设计和性能中的问题有关。适当的研究设计涉及 全面的计划，绩效，文档，分析和出版物。研究 UTMB的方法专家在综合研究设计和统计分析中起着至关重要的作用 高质量，道德临床和转化研究的解释和传播。我们有经验 在整个翻译研究中，具有以患者为中心的生物信息学方面具有特殊专业知识 结果研究/比较有效性研究，大数据库分析，临床试验，数据挖掘， 和网络分析。在此研究方法组件中，我们将解决临床和 翻译研究使我们的CTSA更有效，效率更高，并使我们的研究易于传播 改善全国的健康。为此，我们将向调查人员提供资源 领域生物统计学，流行病学和研究设计。生物统计学流行病学和研究设计 小组将为研究人员轻松获得生物统计学教育/培训，研究设计咨询， 以及创新的工具和方法，以提高临床和转化的质量，严格和效率。这 临床研究办公室将为研究人员和研究团队提供重点的监管知识和 临床试验管理支持。我们将使用创新工具（例如开发应用程序）支持调查人员 评估数据质量和数据挖掘方法，以评估药物治疗相关的毒性。我们也会 应用创新技术来增强试验设计并分析比较有效性的结果 研究。此外，我们将开发一个获得电子同意的过程。我们的研究方法组成部分将增强临床和转化的创新，访问和质量 UTMB的研究。这是通过研究方法，集线器容量和 信息学。我们的研究方法计划包括两个集成的模块。生物统计学，流行病学 研究设计（BERD）团队是UTMB转化研究任务的重要组成部分 提供：基于团队的研究设计和生物统计学协作与咨询；持续教育， 对学生和教师的指导和培训；以及对信息学核心的强烈支持。 Berd将继续 在UTMB开发创新的研究方法中发挥着关键作用，特别强调了增强 临床试验，高级比较有效性研究方法和新型数据管理工具。这 临床研究办公室（OCR）成立于2011年6月，作为研究服务之间的共同计划 和CTSA。这是一个多学科的服务组织，由在赞助临床的团队组成 研究，通过赞助的临床试验和研究人员发起的临床研究项目支持教师。 在我们的创新计分卡的持续改进模型的指导下，我们的集成模块 研究方法组件将解决以下特定目的：