权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

STUDY DESIGN AND CLINICAL RESEARCH CORE

研究设计和临床研究核心

基本信息

批准号：
8474135
负责人：
DAVID Y GRAHAM
金额：
$ 17.22万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2001
资助国家：
美国
起止时间：
2001-04-15 至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/8474135
关键词：
Area Basic Science Biological Biology Biometry Charge Clinical Clinical Investigator Clinical Research Clinical Sciences Clinical Services Clinical Trials Clinical and Translational Science Awards Colon Communities Confidentiality of Patient Information Consent Data Data Analyses Databases Digestive System Disorders Disease 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 Time Tissue Banking Tissue Banks Training Training Programs Translating Translational Research United States Food and Drug Administration United States National Institutes of Health University of Texas M D Anderson Cancer Center Work college comparative effectiveness data management disease registry effectiveness research human tissue interest meetings member microbiome programs sample collection therapy outcome

项目摘要

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.

项目概述（见说明）：