Clinical Research and Protocol Support Services

临床研究和方案支持服务

• 批准号: 9555756
• 负责人: William O'Donnell
• 金额: $ 589.02万
• 依托单位: NATIONAL EYE INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9555756
• 关键词: Age related macular degeneration; Autoimmune Process; Blood Vessels; Cataract; Clinic; Clinical; Clinical Data; Clinical Informatics; Clinical Investigator; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials; Collaborations; Communities; Consult; Consultations; Credentialing; Development; Diagnosis; Diagnostic; Diagnostic Imaging; Diagnostic tests; Disease; Ensure; Eye; Fellowship; Fostering; Funding; Genetic; Grant; Health Personnel; Inflammation; Inherited; Institutes; Intramural Research Program; Investigation; Label; Laboratory Research; Lasers; Lead; Maryland; Metastatic Melanoma; Methodology; Monitor; National Eye Institute; National Heart, Lung, and Blood Institute; National Institute of Allergy and Infectious Disease; Neurocysticercosis; Nutritional; Ophthalmology; Outpatients; Pathology; Patient Care; Patients; Pharmaceutical Preparations; Pharmacology; Phase; Physicians; Prevention; Process; Protocols documentation; Research Infrastructure; Research Personnel; Research Training; Retinal; Safety Management; Services; Source; Students; Supervision; System; Testing; Time; Training; Translations; Travel; United States National Institutes of Health; Vision; Visual system structure; Wegener' s Granulomatosis; clinical application; clinical care; data management; design; diabetic; gene therapy; graft vs host disease; high risk; macular edema; motor disorder; multidisciplinary; neovascularization; patient safety; programs; quality assurance

The clinical program is centrally managed by the Office of the Clinical Director http://www.nei.nih.gov/intramural/cbranch.asp which consists of a state-of-the-art outpatient facility and a multidisciplinary team of ophthalmic physicians, ophthalmic imagers, ophthalmic technicians, and clinical research coordinators, all highly skilled and trained to support clinical research. The Office of the Clinical Director continues to provide core clinical research service support to National Eye Institute investigator during all phases of the clinical research protocol approvals process from concept to approval by the CNS-IRB and until completion. This supports includes; diagnostic, statistical, protocol design, coordinating, regulatory, management, and clinical facilites that enable NEI clinical investigators to focus their time and resourses on developing and conducting inovative and high risk clinical research. This support covered, on average, 40 plus active protocols. A complete description of NEI's intramural scientific portfolio can be found at http://www.nei.nih.gov/intramural/. Specific NEI clinical trials being conducted at the Warren Grant Magnuson Clinical Center in Bethesda, Maryland can be found at http://clinicalstudies.info.nih.gov/cgi/protinstitute.cgi?NEI.0.html and include among others: imaging/diagnostic, diabetic macular edema, cataract, and vision motor disorders; nutritional, pharmacologic, and/or gene therapies for retinal vascular and genetically-inherited ocular diseases; and laser approaches and supplemental methodologies for neovascularization in age-related macular degeneration. In addition the Office of the Clinical Director provides ophthalmic consult services to the NIH community. These consultations provide an interesting mix of rare pathologies such as: neurocysticercosis (NIAID), metastatic melanoma-a disease with autoimmune ocular inflammation (NCI), graft versus host disease with ocular involvement (NHLBI), and Wegener's granulomatosis (NIAID) which has fosterd longterm collaborations and has lead to clinical trials and additional investigations.

临床项目由临床主任办公室集中管理 http://www.nei.nih.gov/intramural/cbranch.asp，该办公室由最先进的门诊设施和一支由眼科医师、眼科成像师、眼科技术人员和临床研究协调员组成的多学科团队组成，所有这些人员均技能精湛且训练有素 支持临床研究。 在临床研究方案批准过程的所有阶段（从概念到 CNS-IRB 批准直至完成），临床主任办公室继续为国家眼科研究所研究者提供核心临床研究服务支持。这支持包括；诊断、统计、方案设计、协调、监管、管理和临床设施，使 NEI 临床研究人员能够将时间和资源集中在开发和开展创新和高风险临床研究上。这种支持平均涵盖 40 多个活动协议。有关 NEI 校内科学组合的完整说明，请访问 http://www.nei.nih.gov/intramural/。在马里兰州贝塞斯达的 Warren Grant Magnuson 临床中心进行的具体 NEI 临床试验可以在 http://clinicalstudies.info.nih.gov/cgi/protinstitute.cgi?NEI.0.html 上找到，其中包括：成像/诊断、糖尿病性黄斑水肿、白内障和视觉运动障碍；针对视网膜血管和遗传性眼部疾病的营养、药物和/或基因疗法；年龄相关性黄斑变性中新生血管形成的激光方法和补充方法。 此外，临床主任办公室还向 NIH 社区提供眼科咨询服务。这些咨询提供了罕见病理学的有趣组合，例如：神经囊尾蚴病（NIAID）、转移性黑色素瘤——一种伴有自身免疫性眼部炎症（NCI）的疾病、伴有眼部受累的移植物抗宿主病（NHLBI）和韦格纳肉芽肿病（NIAID），这些疾病促进了长期合作并导致了临床试验和其他研究。