Clinical Research & Study Design Core

项目总结/摘要：研究设计和临床研究核心（临床核心） 德克萨斯医学中心消化系统研究设计和临床研究核心的主要功能 疾病中心（DDC）是（1）为消化系统疾病的临床和基础科学研究者提供服务， 全面的研究设计咨询和支持，（2）协助DDC研究者在研究设计的各个方面， 获取消化系统疾病研究所需的临床标本，（3）开发疾病特异性 数据库和储存库，并支持全面的数据分析和基本的解释，翻译， 临床和流行病学研究。这个核心的具体目标是成功地执行这些功能。 主要核心服务包括：提供研究设计和药物分析支持; 数据管理和数据库组织，以促进有效的分析;协助DDC调查人员 获取研究所需的临床标本;协助和培训合规性，患者 保密和监督问题，包括准备IRB要求和准备研究性新闻 药物应用;并通过会议和研讨会教育成员。 在本供资期间取得的成就包括扩大样本和组织收集， 银行，以及涉及流行病学和健康结果研究的请求数量增加，特别是 使用电子数据库获取大量患者信息、风险因素、治疗方法， 这些数据库包括大型疾病登记和医疗保健索赔数据。临床核心将 继续支持建立类器官生物储存库，并扩大标本收集服务， 从癌前病变处收集组织。 我们提出了新的DDC会员专属服务，包括先进的统计分析程序，人工 智能和机器学习，以及因果推理建模的指导。新的数据管理 服务已经集成，包括REDCap、仪表板和与实验室接口的应用程序 和临床方面的核心。我们还预计，对卫生服务相关专业知识的需求将有所增长 来自新招募的研究人员和NIDDK培训计划的消化系统疾病研究， 胃肠疾病的流行病学和结果。临床中心还将扩大标本采集服务 收集样本用于评估重金属暴露;这项新协议受到 研究人员研究重金属暴露在胃肠道和肝脏损伤和炎症中的作用。 在当前的资助周期内，22名DDC成员使用了核心，累计使用了13，500多个小时。 的服务.我们支持了24项资助申请（30%已经获得资助）和200篇同行评审的出版物。

PROJECT SUMMARY/ABSTRACT: Study Design and Clinical Research Core (Clinical Core) The major functions of the Study Design and Clinical Research Core of the Texas Medical Center Digestive Disease Center (DDC) are to (1) serve clinical and basic science investigators in digestive diseases with comprehensive study design consultation and support, (2) assist DDC investigators in all aspects of the acquisition of clinical specimens required for their research in digestive diseases, (3) develop disease-specific databases and repositories, and support comprehensive data analyses and interpretation of basic, translation, clinical and epidemiological studies. The Specific Aims of this core are to successfully execute these functions. Major Core services include: providing study-design and statistical-analysis support; establishing procedures for data management and database organization to facilitate efficient analyses; assisting DDC investigators in acquiring clinical specimens needed for their research; assisting and training in compliance, patient confidentiality and oversight issues, including preparation of IRB requests and preparation of Investigational New Drug applications; and educating members via meetings and seminars. Achievements during the current funding period include the expansion of sample and tissue collection and banking, and the increased number of requests involving epidemiology and health outcomes research, especially those using electronic databases to capture large amounts of patient information, risk factors, therapies, and outcomes; these databases include large disease registries and healthcare claims data. The Clinical Core will continue to support establishment of the organoid biorepository and expand the specimen collection service to collect tissue from preneoplastic lesions. We propose new DDC member-exclusive services that include advanced statistical analytical programs, artificial intelligence and machine learning, and guidance with causal inference modeling. New data management services have been integrated including REDCap, dashboards, and applications that interface with laboratory and clinical aspects of the Core. We also anticipate the growth of demand for expertise related to health services research in digestive diseases from newly recruited investigators and the NIDDK training program in epidemiology and outcomes of GI diseases. The Clinical Core will also expand the specimen collection service to collect specimens for assessing exposure to heavy metal; this new protocol is highly sought after by investigators studying the role of heavy metals exposure in gastrointestinal and hepatic injury and inflammation. Twenty-two DDC members used the Core during the current funding cycle, accruing more than 13,500 hours of service. We supported 24 grant applications (30% already funded) and 200 peer-reviewed publications.