Clinical

临床

• 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
• 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

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.

临床研究核心是转化中心不可或缺的组成部分，因为它旨在1）协助研究者访问，选择和招募囊性纤维化和对照患者进行临床试验，并节约中心的患者资源。2)协助研究者规划和执行临床试验，3）监督和/或执行测试和程序，包括质量控制。4)监督生物标本的采集和处理，包括SAL液和细胞样本、鼻灌洗液/细胞和刮取的鼻上皮细胞、痰液（诱导和吐出）、呼出气冷凝液、血液、尿液和粪便，5）维护从当前和以前的患者收集的样本的标本和组织库6）维护克利夫兰CF中心自成立以来所有患者的数据库（共1619例患者; 348例活跃患者），以便为临床试验和研究、回顾性临床研究选择患者，并与各种国家数据库合作。7)促进将基础科学研究者的发现转化为临床研究（如适用），包括制定适用于特定研究的结局指标;并让基础科学家参与研究临床实践或临床研究中发现的问题。该核心使我们的良好特征的患者人群可用于临床研究，并促进了我们基础科学实验室的想法从实验室到床边的转化。核心支持的临床项目还产生假设，这些假设又被送回基础科学实验室进行更详细的研究。