Study Design & Clinical Research Core

学习规划

• 批准号: 10377550
• 负责人: FASIHA KANWAL
• 金额: $ 16.43万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10377550
• 关键词: Area; Award; Basic Science; Biometry; Clinical; Clinical Research; Clinical Sciences; Clinical Trials; Clinical and Translational Science Awards; Collection; Confidentiality of Patient Information; Consultations; Data; Data Analyses; Databases; Development; Digestive System Disorders; Disease; Ensure; Epidemiology; Funding; Gastrointestinal Injury; Goals; Grant; Growth; Health; Health Services Research; Healthcare; Human; Human Resources; Inflammation; Institutional Review Boards; Instruction; Investigational New Drug Application; Laboratory Finding; Laboratory Research; Link; Liver; Medical center; Medicine; Organoids; Outcomes Research; Patients; Population; Preparation; Procedures; Protocols documentation; Research; Research Design; Research Personnel; Resources; Risk Factors; Scientific Inquiry; Scientist; Services; Specific qualifier value; Specimen; Statistical Data Interpretation; Texas; Tissue Banks; Tissues; Training; Training Support; Translating; Translational Research; Translations; base; biobank; college; data management; disease registry; epidemiology study; experience; human tissue; innovation; member; prevent; recruit; sample collection; service coordination; statistical service; therapy outcome; translational study

Project Summary The major functions of the Study Design and Clinical Research Core 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, and (3) support comprehensive data analyses and interpretation of basic, translation, clinical and epidemiological studies. The Core has been highly productive and beneficial for members of the TMC DDC. In the last 4 years, 29 members used the study design consultation and support services, 49 DDC members used the statistical component of the Core, and 13 members obtained help with specimen acquisition and handling. This Core is primarily a DDC Core; 75% of Core users in the last 2 years were either full or associate members of the DDC. Over 50 members anticipate using this Core in the next project period. 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 training. The Clinical Core fulfills an important need for the DDC investigators at Baylor College of Medicine (BCM), where there is no department of epidemiology or biostatistics or a funded Clinical Translational Science Award grant. For the new funding period, Core E will continue to support ongoing and innovative research to prevent and cure digestive diseases. We also propose new DDC member-exclusive services that include cutting edge statistical analyses, enhanced research coordination service, and establishment of a enteroid biorepository. Both Core Co-Directors brings a unique area of expertise in clinical, translational, and epidemiological research, namely sample and tissue collection, epidemiology and health services research, and biostatistics. Advances 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. During the current award cycle, the has been critically involved in developing the new service in the newly reorganized GEMS Core of the DDC, providing human organoids to DDC investigators. The Core will continue to support establishment of the enteroid biorepository and expand the specimen collection service to collect tissue from livers. This service is highly sought after and will be shared with researchers studying gastrointestinal injury and inflammation.

项目摘要 研究设计和临床研究核心的主要功能是（1）服务于临床和基础研究 消化系统疾病的科学研究者，提供全面的研究设计咨询和支持，（2） 协助DDC研究者获取其研究所需的临床标本的各个方面， 消化系统疾病，以及（3）支持全面的数据分析和基础、翻译、 临床和流行病学研究。核心小组的工作卓有成效， TMC DDC在过去的4年里，29名成员使用了研究设计咨询和支持服务， 49名DDC成员使用了核心的统计组件，13名成员获得了样本帮助 收购和处理。此核心主要是DDC核心;过去两年中75%的核心用户 DDC的正式或准成员。超过50名成员预计在下一个项目中使用此核心 期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 研究者获取其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IRB要求的准备和 研究性新药（IND）申请;和培训。临床核心满足了以下重要需求： 贝勒医学院（BCM）的DDC研究人员，该学院没有流行病学系 或生物统计学或临床转化科学奖资助。在新的供资期，核心E 将继续支持正在进行的创新研究，以预防和治疗消化系统疾病。我们也 提出新的DDC会员专属服务，包括尖端的统计分析，增强 研究协调服务，并建立了一个类肠生物储藏库。两位核心联合董事带来了 一个独特的专业领域，在临床，转化和流行病学研究，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。本期预付款 资助期间包括扩大样本和组织收集和银行，并增加 涉及流行病学和健康结果研究的请求数量，特别是使用电子 数据库，以捕获大量的患者信息，风险因素，治疗和结果;这些 数据库包括大型疾病登记和医疗保健索赔数据。在当前的奖励周期内， 在DDC新重组的GEMS核心中， 为DDC研究人员提供人类类器官核心将继续支持建立 肠状生物储存库，并扩大标本收集服务，从肝脏收集组织。此服务 是非常抢手的，并将与研究胃肠损伤和炎症的研究人员分享。