Clinical

临床

基本信息

批准号：
8705740
负责人：
Mitchell L Drumm
金额：
$ 8.24万
依托单位：
CASE WESTERN RESERVE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-04-01 至 2015-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8705740
关键词：
Adverse event Advisory Committees Animals Basic Science Biological Process Blood Bronchoalveolar Lavage Budgets Cells Chloride Ion Chlorides Clinic Clinical Clinical Data Clinical Research Clinical Trials Collection Contracts Cystic Fibrosis DEXA Data Databases Development Diffusion Documentation Epithelial Epithelial Cells Exercise stress test Exhalation Feces Gases Goals Husband Imaging Techniques Industry Infant Institutional Review Boards Investigation Irrigation Liquid substance Measurement Metabolic Nasal Lavage Fluid Nitric Oxide Nose Oscillometry Outcome Measure Patient Selection Patients Plasma Plethysmography Population Research Pre-Clinical Model Preparation Procedures Process Protocols documentation Pulmonary function tests Quality Control Radiology Specialty Recruitment Activity Reporting Research Personnel Resources Sampling Schedule Scientist Services Source Specimen Spirometry Sputum Sweat test Testing Thoracic Radiography Tissue Banking Tissue Banks Tissues Translational Research Translations Urine Walking bench to bedside clinical practice cystic fibrosis patients design patient population performance tests programs research study

项目摘要

The Clinical Studies Core is an integral component the Translational Center as it is designed to 1) Assist investigators in accessing, selecting, and recruiting cystic fibrosis and control patients for clinical trials and to husband the patient resources of the Center. 2) Assist investigators in the planning and execution of clinical trials, 3) Provide oversight and/or performance of tests and procedures, including quality control. 4) Provide oversight of collection and processing of biologic specimens, including SAL fluid and cell samples, nasal lavage fluid/cells and nasal epithelial cells from scrapping, sputum (induced and expectorated), exhaled breath condensate, blood, urine, and stool, 5) Maintain a specimen and tissue bank of samples collected from current arid former patients 6) Maintain the database for all patients ever seen at the Cleveland CF Center since its inception (1619 total patients; 348 active patients) for purposes of patient selection for clinical trials and studies, retrospective clinical studies and cooperation with various national databases. 7) Facilitate the translation of discoveries made by basic science investigators into clinical investigation where applicable, including the development of outcome measures appropriate for specific studies; and to engage basic scientists to investigate questions identified in clinical practice or clinical studies. This Core makes available our well-characterized patient population for clinical studies and facilitates the bench to bedside translation of ideas from our basic science labs. The Core-supported clinical projects also generate hypotheses that are in turn returned to basic science labs for more detailed investigation.

临床研究核心是翻译中心不可或缺的组成部分，因为它旨在1）协助研究人员访问，选择和招募囊性纤维化和控制患者进行临床试验，并丈夫丈夫该中心的患者资源。 2）协助调查人员计划和执行临床试验，3）提供测试和程序的监督和/或性能，包括质量控制。 4）提供对生物学标本的收集和加工的监督，包括盐液和细胞样品，鼻腔灌洗液/细胞和鼻皮细胞，从刮擦，痰液（诱导和期望），呼出的呼吸凝结，血液，血液，尿液，尿液和粪便，5）保持在当前的患者6）的呼吸凝结，血液，尿液，尿液和粪便6） CF中心自成立以来（1619名患者总患者； 348名活跃患者），目的是患者选择临床试验和研究，回顾性临床研究以及与各种国家数据库的合作。 7）促进基础科学研究者对临床研究的发现的转化，包括适用于特定研究的结果指标的制定；并吸引基本科学家研究在临床实践或临床研究中发现的问题。该核心使我们为临床研究良好的患者人群提供了良好的患者人群，并促进了基础科学实验室想法的床边翻译。核心支持的临床项目还产生了假设，而假设又返回基础科学实验室进行了更详细的研究。