Clinical Research and Protocol Support Services

临床研究和方案支持服务

• 批准号: 10930600
• 负责人: William O'Donnell
• 金额: $ 956.18万
• 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/10930600
• 关键词: Age related macular degeneration; Autoimmune; 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 Services; Disease; Education; Ensure; Eye; Eye diseases; Fellowship; Fostering; Funding; Genetic; Grant; Health Personnel; Image; Inflammation; Infrastructure; Inherited; Institutional Review Boards; Intramural Research Program; Investigation; 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; Office Management; Ophthalmology; Pathology; Patient Care; Patients; Phase; Physicians; Prevention; Process; Protocols documentation; Research Personnel; Research Training; Resources; Retinal gene therapy; Safety Management; Services; Source; Students; System; Testing; Time; Training; Translations; Travel; United States National Institutes of Health; Vision; Visual System; Wegener' s Granulomatosis; clinical application; clinical care; clinical center; data management; design; diabetic; graft vs host disease; high risk; imager; innovation; macular edema; motor disorder; multidisciplinary; neovascularization; off-label drug; outpatient facility; patient safety; pharmacologic; programs; quality assurance; skills; testing services

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 the 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 support includes; diagnostic, statistical, protocol design, coordinating, regulatory, management, and clinical facilities that enable NEI clinical investigators to focus their time and resources on developing and conducting innovative 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 fostered longterm collaborations and has lead to clinical trials and additional investigations.

该临床项目由临床主任办公室（http://www.nei.nih.gov/intramural/cbranch.asp）集中管理，该办公室由最先进的门诊设施和眼科医生、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，所有人员都训练有素，训练有素，能够支持临床研究。 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。这种支持包括;诊断、统计、方案设计、协调、监管、管理和临床设施，使NEI临床研究者能够将时间和资源集中在开发和开展创新和高风险的临床研究上。这一支持平均涵盖40多项现行协议。NEI校内科学组合的完整描述可以在http://www.nei.nih.gov/intramural/上找到。在马里兰州贝塞斯达的Warren Grant Magnuson临床中心进行的具体NEI临床试验可在http://clinicalstudies.info.nih.gov/cgi/protinstitute.cgi?上找到NEI.0.html，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;视网膜血管和遗传性眼病的营养，药理学和/或基因疗法;以及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，临床主任办公室还为NIH社区提供眼科咨询服务。这些咨询提供了一个有趣的混合罕见的病理，如神经囊尾蚴病（NIAID），转移性黑色素瘤-一种疾病与自身免疫性眼部炎症（NCI），移植物抗宿主病与眼部受累（NHLBI），韦格纳肉芽肿病（NIAID），这促进了长期的合作，并导致临床试验和其他调查。