STUDY DESIGN AND CLINICAL RESEARCH CORE

项目总结（见说明）： 研究设计和临床研究核心的主要功能是（1）协助消化系统疾病的临床和基础科学研究者进行适当的研究设计、统计分析和数据解释，以及（2）协助这些研究者获取其消化系统疾病相关研究所需的临床标本。这个核心一直是高效和有益的TMC消化疾病中心的成员。在过去的4年里，22个正式成员使用了这个核心，20个准成员和试点和可行性（P/F）获奖者也使用了这个核心。主要核心服务包括提供研究设计和药物分析支持;建立数据管理和数据库组织程序，以促进有效分析;协助DDC研究者获取研究所需的临床标本;协助和培训合规性、患者保密性和监督问题，包括准备IRB要求和准备研究新药（IND）申请;并通过会议和研讨会教育成员。三位核心联合主任都在临床和转化研究方面拥有独特的专业知识，即样本和组织收集，流行病学和卫生服务研究以及生物统计学。这三个核心联合董事有一个良好的记录，与DDC，公共卫生，卫生服务研究科在密歇根大学的UT学校的研究人员合作，和得克萨斯大学医学博士。安德森癌症中心。过去4年的进展包括样本和组织收集和储存的扩大，以及涉及流行病学和健康结局研究的请求数量增加，特别是那些使用电子数据库获取大量患者信息、风险因素、治疗和结局的请求;这些数据库包括大型疾病登记和医疗保健索赔数据。临床核心一直在积极参与开发新的人类类器官（在综合生物学核心）和微生物组服务在DDC。我们预计基础和翻译DDC研究人员对生物样品采集的需求将增长，这是由于使用综合生物学进行类器官培养和微生物组核心的研究增加。我们还预计，新招募的研究人员和新资助的T-32 NIDDK流行病学和GI疾病结局培训计划对消化系统疾病卫生服务研究相关专业知识的需求将增长。

PROJECT SUMMARY (See instructions): The major functions of the Study Design and Clinical Research Core are to (1) assist clinical and basic science investigators in digestive diseases with appropriate study design, statistical analyses, and data interpretation, and (2) assist these investigators in acquiring clinical specimens required for their digestive disease-related research. This Core has been highly productive and beneficial for members of the TMC Digestive Diseases Center. In the last 4 years, 22 Full Members used this Core as did 20 Associate members and Pilot and Feasibility (P/F) Awardees. 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 (IND) applications; and educating members via meetings and seminars. Each of the three Core Co-Directors brings a unique area of expertise in clinical and translational research, namely sample and tissue collection, epidemiology and health services research, and biostatistics. The three Core Co-Directors have a strong track record of collaborative work with investigators at the DDC, The UT-School of Public Health, Health Services Research Section at BCM, and The University of Texas M.D. Anderson Cancer Center. Advances during the past 4 years 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 has been critically involved in developing the new human organoid (within the Integrative Biology Core) and microbiome services at the DDC. We anticipate the growth of demand for biological sample collections from basic and translational DDC investigators due to the increase in research using the Integrative Biology for organoid cultures and Microbiome Core. We also anticipate the growth of demand for expertise related to health services research in digestive diseases from newly recruited investigators and the newly funded T-32 NIDDK training program in epidemiology and outcomes of Gl diseases.