STUDY DESIGN AND CLINICAL RESEARCH CORE

研究设计和临床研究核心

• 批准号: 9242621
• 负责人: DAVID Y GRAHAM
• 金额: $ 17.21万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-04-15 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9242621
• 关键词: Area; Basic Science; Biological; Biology; Biometry; Cancer Center; Charge; Clinical; Clinical Investigator; Clinical Research; Clinical Sciences; Clinical Trials; Clinical and Translational Science Awards; Colon; Communities; Confidentiality of Patient Information; Consent; Data; Data Analyses; Databases; Digestive System Disorders; Disease; Doctor of Medicine; Effectiveness; Epidemiology; Esophagus; Funding; Future; Grant; Growth; Health; Health Services Research; Healthcare; Human; Infection; Injury; Institutional Review Boards; Instruction; Intestines; Investigational New Drug Application; Knowledge; Laboratory Research; Link; Medicine; National Institute of Diabetes and Digestive and Kidney Diseases; Organoids; Outcome; Outcomes Research; Patients; Population; Preparation; Procedures; Process; Public Health Schools; Recruitment Activity; Research; Research Design; Research Personnel; Research Project Grants; Resources; Risk Factors; Sampling; Scientist; Services; Small Intestines; Specimen; Statistical Data Interpretation; Stem cells; Structure; Surveys; Texas; Time; Tissue Banks; Training; Training Programs; Translating; Translational Research; United States Food and Drug Administration; United States National Institutes of Health; Universities; Work; college; comparative effectiveness; data management; disease registry; effectiveness research; epidemiology study; human tissue; interest; meetings; member; microbiome; programs; sample collection; therapy outcome

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.

项目总结(见说明)： 研究设计和临床研究核心的主要职能是(1)通过适当的研究设计、统计分析和数据解释，协助消化疾病的临床和基础科学研究人员，以及(2)帮助这些研究人员获取与消化疾病相关的研究所需的临床标本。这一核心对TMC消化疾病中心的成员具有很高的生产力和益处。在过去的4年里，22个正式成员和20个准成员以及试点和可行性(P/F)奖获得者使用了这一核心。主要核心服务包括提供研究设计和统计分析支持；建立数据管理和数据库组织程序，以促进有效分析；协助疾病预防控制中心调查人员获取研究所需的临床标本；在合规、患者保密和监督问题方面协助和培训，包括准备IRB请求和准备研究新药(IND)申请；以及通过会议和研讨会教育成员。三位核心联席主任中的每一位都在临床和转译研究方面带来了独特的专业知识，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。三位Core联席董事在与DDC、德克萨斯大学公共卫生学院、BCM医疗服务研究部和德克萨斯大学M.D.安德森癌症中心的研究人员合作方面有着良好的合作记录。过去4年的进展包括样本和组织收集及银行业务的扩大，以及涉及流行病学和健康结果研究的请求数量的增加，特别是那些使用电子数据库来捕获大量患者信息、风险因素、治疗和结果的请求；这些数据库包括大型疾病登记和医疗保健索赔数据。临床核心在开发新的人类器官(在综合生物学核心内)和DDC的微生物组服务方面发挥了关键作用。我们预计，由于使用有机培养综合生物学和微生物组核心的研究增加，基础和翻译DDC研究人员对生物样本收集的需求将会增长。我们还预计，新招募的研究人员以及新资助的T-32 NIDDK流行病学和G1疾病结果培训计划对消化系统疾病健康服务研究方面的专业知识的需求将会增长。