STATISITICAL DESIGN, MONITORING & COORD. OF VISION CLINICAL TRIALS & EPIDEMIOLOGY

统计设计、监测

基本信息

批准号：
9004297
负责人：
KERI HAMMEL
金额：
$ 589.28万
依托单位：
THE EMMES COMPANY, LLC
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-11-01 至 2016-10-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9004297
关键词：
1 year old 10 year old 12 year old 18 year old 21 year old 220kDa rod outer segment rim protein 5 year old Accounting Acquired Immunodeficiency Syndrome Adoption Adrenal Cortex Hormones Adult Adverse effects Adverse event Affect Age Age related macular degeneration Age-Years Air Air Pressure Alzheimer&apos s Disease Ambulatory Care Facilities American Amino Acids Analytical Chemistry Angiography Animals Anti-Inflammatory Agents Anti-inflammatory Antibiotics Antigens Appearance Area Area Analyses Audiometry Authorization documentation Autoimmune Diseases Autologous Automobile Driving Back Bacteria Behcet Syndrome Bilateral Biological Biopsy Birth Blindness Blinking Blood Blood Cells Blood Circulation Blood Pressure Blood Tests Blood Vessels Blood donor Blood specimen Body Fluids Body Weight Bone Density Bone Marrow Brain Caloric Tests Canis familiaris Caring Case-Control Studies Cataract Cauterization - action Cell Line Cells Cheek structure Chemicals Chemistry Child Cholesterol Chronic Ciliary Neurotrophic Factor Clinic Clinic Visits Clinical Clinical Research Clinical Trials Code Collaborations Collecting Cell Collection Coloboma Colon Color Color Visions Complication Computers Cone Conjunctival Epithelium Consultations Contact Lenses Contractor Contracts Cornea Corneal Diseases Corneal dystrophy Coughing Cross-Over Studies Crystalline Lens Cyclosporins Cyst Cystoid Macular Edema DNA DNA Repository DNA Sequence Alteration Dark Adaptation Darkness Data Data Analyses Data Collection Data Coordinating Center Data Storage and Retrieval Databases Date of birth Decision Making Defect Deglutition Deposition Development Devices Dextromethorphan Diabetes Mellitus Diabetic Retinopathy Diagnosis Diagnostic Procedure Diagnostic tests Diet Discipline of Nursing Disease Disease Management Dislocations Documentation Dose Drops Drug Compounding Drug Delivery Systems Drug Formulations Drug Implants Drug Kinetics Drug Stability Drug toxicity Dryness Dyes Ear Early treatment Earwax Economics Effectiveness Electrodes Electron Microscopy Electrooculography Electroretinography Eligibility Determination Enrollment Environment Epidemiology Epigenetic Process Equilibrium Equipment and supply inventories Erythrocytes Evaluation Evaluation Studies Event Evoked Potentials External auditory canal Extramural Activities Extravasation Eye Eye Color Eye Movements Eye Part Eye diseases Eyedrops Face Family Family history of Family member Feces Fetus Florida Fluocinolone Acetonide Fluorescein Fluorescein Angiography Food, Drug and Cosmetic Act Forehead Future Gender Gene Mutation Gene Transfer Genealogical Tree Generations Genes Genetic Genetic Counseling Genetic Markers Genetic Research Genetic screening method Genetic study Genotype Gland Glaucoma Goggles Government Guidelines Hair Hair follicle structure Hand Head Health Health Sciences Healthcare Hearing Hearing Impaired Persons Hearing Tests Height Hematopoietic stem cells Hereditary Disease High Pressure Liquid Chromatography Hip region structure Home environment Hospitals Hour Human Human Resources Hydroxychloroquine Hyperpigmentation Hypersensitivity skin testing Ibuprofen Image Immune Immune System Diseases Immune response Immune system Immunogenetics Immunology Immunosuppressive Agents Implant Incidental Findings India Individual Indocyanine Green Inflammation Inflammation Mediators Inflammatory Inherited Injection of therapeutic agent Institutes Institution Institutional Review Boards Interferon gamma 1b Interleukin-1 Interview Intestines Intramural Research Intravenous Investigation Iris Joints Keratitis Keratopathy Knowledge Label Laboratories Laboratory Animals Labyrinth Laser Surgery Lead Learning Left Legal Blindness Letters Lifting Light Lighting Link Liquid substance Local anesthesia Location Lupus Macular degeneration Maintenance Malignant Neoplasms Manuals Manuscripts Maryland Masks Measurement Measures Mediating Medical Medical Genetics Medical History Medical Imaging Medicare Medicine Membrane Memory Metals Methods Microglia Minocycline Molecular Molecular Biology Molecular Diagnosis Molecular Genetics Monitor Monkeys Moods Movement Mucous Membrane Multicenter Trials Muscle Mutation Mydriasis Myopia National Eye Institute National Heart, Lung, and Blood Institute Nationalities Natural History Nature Neck Needles Neuraxis Neurologic Neurons Normal saline Normal tissue morphology Nose Oculocutaneous Albinism Ointments Operative Surgical Procedures Ophthalmic examination and evaluation Optic Nerve Optical Coherence Tomography Oral Oral cavity Oregon Organ Oryctolagus cuniculus Otoscopes Outcome Outcome Measure Outcomes Research Outpatients Pain Painless Pakistan Parents Participant Patient Recruitments Patients Patients&apos Rooms Pattern Perimetry Personality Persons Pharmaceutical Preparations Pharmacy facility Phase Phenotype Photography Physical Examination Physicians Physiological Pigmentation physiologic function Pigments Pilot Projects Placebos Population Population Study Populations at Risk Positioning Attribute Preclinical Testing Pregnancy Pregnancy Tests Preparation Principal Investigator Procedures Process Production Proteins Proteome Protocols documentation Pupil Quality-of-Life Assessment Questionnaires Randomized Randomized Clinical Trials Reading Recommendation Recording of previous events Records Recruitment Activity Relative (related person)Reproducibility Research Research Design Research Personnel Resources Rest Retina Retinal Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Retinitis Pigmentosa Review Committee Rheumatoid Arthritis Safety Saliva Sampling Sampling Studies Scanning Schedule Schizophrenia Sclera Scleritis Secure Series Serum Services Severities Siblings Side Signal Transduction Signs and Symptoms Silver Sirolimus Site Skin Skin Tissue Solutions Somatic Cell Source Specialist Specific qualifier value Specimen Speech Speed Spottings Staging Stargardt&apos s disease Stem cell transplant Stem cells Steroids Stomach Strabismus Stream Sunlight Surface Surveys Swab Swelling Switzerland Symptoms Syndrome System T-Lymphocyte Techniques Telangiectasis Telephone Tennessee Testing Texas Therapeutic immunosuppression Thick Thigh structure Thinking Thyroid Gland Time Tissue Sample Tissues Toxic effect Trademark Training Transplant Recipients Transplantation Travel Treatment Failure Treatment Protocols Tuberculosis Tyrosine Ultraviolet Rays United States United States National Institutes of Health Universities Upper arm Urine Use Effectiveness Usher Syndrome Uveitis Validation Variant Veins Vertebral column Virus Vision Vision Disorders Vision Tests Visit Visual Visual Acuity Visual Fields Visual Motor Coordinations Visual impairment Vitamins Vitelliform macular dystrophy Walking Water Weight Weights and Measures West Virginia Work X-Linked Retinoschisis XLRS1 protein achromatopsia active method adaptive optics age related alternative treatment analog arm balance testing base biobank bone central retinal vein occlusion checkup examination chronic graft versus host disease clinical epidemiology clinically relevant college computerized data processing congenital cataract corneal epithelium cost effectiveness data management deafness density design diabetic diagnosis evaluation diaries digital imaging disease-causing mutation disorder of macula of retina drug distribution drug standard effective therapy efficacy testing eligible participant enema administration evaluation/testing exome exome sequencing experience eye blood vessel fatherhood follow-up fovea centralis gene function gene therapy gene transfer vector genetic makeup genome sequencing geographic atrophy graft vs host disease healthy volunteer hearing impairment hip bone improved inclusion criteria induced pluripotent stem cell inherited retinal degeneration inhibitor/antagonist instrument interest irritation lacrimal lens light microscopy macula macular edema male medical schools meetings microbiome middle ear neovascularization new growth novel novel therapeutics ocular pain open label operation optical imaging patient expectation patient safety pill preclinical study pregnant pressure prevent primary outcome proband prospective protocol development psychologic rectal repository research study response safety testing sample collection screening secondary outcome sham surgery sham-controlled study sound stability testing standard care standard of care success trait treatment effect treatment trial tv watching vector volunteer wasting working group

项目摘要

This contract is designed to attain extramural support for developing, designing, interpreting, and evaluating clinical trials, epidemiologic and natural history studies. In addition, it will provide for outcomes research involving eye diseases and visual disorders and some preclinical studies. The focus shall be on the design of studies and the collection, analysis, and interpretation of data emanating from these studies, as well as support, and monitoring patient safety and follow-up. Contractor shall also provide analytical and data management support, as described in the work statement, for specified clinical research data bases, cost-effectiveness and economic analyses, quality of life assessment and outcomes research. This will include, but not be limited to, the following areas: analysis of Medicare and other health care databases; evaluation of existing NEI databases such as, centralized NEI Intramural Research database, the Eye Disease Case Control Study, Early Treatment Diabetic Retinopathy Study, Framingham Eye Study, and intramural AIDS and uveitis databases. The 46 active/follow-up trials in 2015 are listed below: For more info: http://clinicalstudies.info.nih.gov/cgi/protinstitute.cgi?NEI.0.html 15-EI-0202: Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated with Age-Related Macular Degeneration * 15-EI-0128: The Genetics of Inherited Eye Disease * 15-EI-0052: Pilot Phase I/II Study of the Evaluation of Interferon Gamma-1b Administered Topically for Macular Edema/Intraretinal Schisis Cysts in Rod-Cone Dystrophy (RCD) and Enhanced S-Cone Syndrome (ESCS) * 15-EI-0041: Patient Expectations When Enrolling in an Early-Phase Clinical Trial * 15-EI-0038: A Phase I/IIa Study of RS1 Ocular Gene Transfer for X-linked Retinoschisis * 15-EI-0020: Adaptive Optics Retinal Imaging * 14-EI-0173: An Investigation of Retinal Findings in Patients with Signs and Symptoms of Alzheimer's Disease Enrolled in 09-M-0198 * 14-EI-0171: The Focal Electro-Oculogram in Macular Disease * 14-EI-0108: Pilot Study to Evaluate Oral Minocycline in the Treatment of Cystoid Macular Edema Associated with Retinitis Pigmentosa * 14-EI-0078: A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel) * 14-EI-0064: Whole Exome and Whole Genome Sequencing for Genotyping of Inherited and Congenital Eye Conditions * 13-EI-0154: Color Vision as an Outcome Measure for Clinical Trials of Inherited Retinal Degenerations * 13-EI-0124: A Pilot Study of Nitisinone in the Treatment of Oculocutaneous Albinism, Type 1B * 13-EI-0072: Microbiome and Ocular Inflammatory Disease * 13-EI-0049: Genetics of Uveal Coloboma * 12-EI-0203: Natural History of ABCA4-Related Retinopathies * 12-EI-0042: NEI Intramural Biorepository for Retinal Diseases * 11-EI-0264: A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Central Retinal Vein Occlusions * 11-EI-0263: A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Branch Retinal Vein Occlusions * 11-EI-0245: Generation of Induced Pluripotent Stem (iPS) Cell Lines from Somatic Cells of Participants with Eye Diseases and from Somatic Cells of Matched Controls * 11-EI-0173: The Natural History of Ocular Graft-Versus Host Disease * 11-EI-0147: Longitudinal Investigation of Dark Adaptation in Participants with Age-Related Macular Degeneration * 10-EI-0140: Genotype-Phenotype Study of Patients with Plaquenil -Induced Retinal Toxicity, with Evaluation of the ABCA4 Gene * 10-EI-0093: Immunogenetic Mechanisms in Behcet's Disease * 10-EI-0016: Internal Monitoring of Eye Movement in Schizophrenia * 08-EI-0169: Evaluation and Treatment Protocol for Potential Research Participants with Ocular Diseases * 08-EI-0102: Screening Study for the Evaluation and Diagnosis of Potential Research Participants * 08-EI-0099: Epigenetics, Molecular Genetics, and Biomarkers of Degenerative and Inflammatory Ocular Diseases * 08-EI-0043: Age-Related Eye Disease Study (AREDS) and AREDS2 Follow-Up * 08-EI-0031: Visual Motor Coordination * 06-EI-0236: National Ophthalmic Genotyping and Phenotyping Network, Stage 1 - Creation of DNA Repository for Inherited Ophthalmic Diseases * 06-EI-0068: The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease * 06-EI-0059: Clinical and Molecular Studies in Families with Glaucoma and Related Diseases * 06-EI-0058: Clinical and Molecular Studies in Families with Myopia and Related Diseases * 05-EI-0143: Molecular Genetics of Retinal Degenerations * 04-EI-0008: Clinical and Molecular Studies in Families with Corneal Dystrophy or Other Inherited Corneal Diseases * 03-EI-0123: Clinical and Molecular Studies in Families with Congenital or Hereditary Cataracts * 03-EI-0122: Evaluation of Immune Responses to Different Antigens in Non Infectious Ocular Inflammatory Diseases * 03-EI-0033: X-Linked Juvenile Retinoschisis - Clinical and Molecular Studies 13-EI-0206: A Randomized, Controlled, Double-Masked, Clinical Trial of Autologous Serum Eye Drops for Severe Ocular Chronic Graft-versus-Host Disease (GVHD) in Hematopoietic Stem Cell Transplant (HSCT) Patients * 13-EI-0102: Gevokizumab Treatment for Active Scleritis By IL-1 Inhibition (GATSBY) * 12-EI-0167: A Phase I/II Study of the NT-501 Intraocular Implant Releasing Ciliary Neurotrophic Factor (CNTF) in Participants with CNGB3 Achromatopsia * 11-EI-0244: A Pilot Phase I/II Study for the Evaluation of Dextromethorphan as a Microglia Inhibitor in the Treatment of Diabetic Macular Edema (MiDME2) * 07-EI-0213: Laboratory of Immunology/National Eye Institute Repository * 06-EI-0050: Multicenter Uveitis Steroid Treatment (MUST) Trial Protocol * 05-EI-0096: Natural History and Genetic Studies of Usher Syndrome

该合同旨在为开发、设计、解释和评估临床试验、流行病学和自然史研究获得外部支持。此外，还将提供涉及眼部疾病和视觉障碍的结果研究以及一些临床前研究。重点应放在研究设计以及这些研究数据的收集、分析和解释，以及支持和监测患者安全和随访上。承包商还应为指定的临床研究数据库、成本效益和经济分析、生活质量评估和结果研究提供工作说明书中所述的分析和数据管理支持。这将包括但不限于以下领域：医疗保险和其他医疗保健数据库的分析；评估现有的 NEI 数据库，例如中央 NEI 校内研究数据库、眼病病例对照研究、早期治疗糖尿病视网膜病变研究、弗雷明汉眼科研究以及校内艾滋病和葡萄膜炎数据库。 2015 年的 46 项活跃/后续试验如下：欲了解更多信息：http://clinicalstudies.info.nih.gov/cgi/protinstitute.cgi?NEI.0.html 15-EI-0202：口服米诺环素治疗年龄相关性黄斑变性地理萎缩的评价 * 15-EI-0128：遗传性眼病的遗传学 * 15-EI-0052：干扰素 Gamma-1b 局部给药治疗视杆细胞营养不良 (RCD) 和增强型视锥细胞综合征 (ESCS) 黄斑水肿/视网膜内分裂囊肿的 I/II 期试点研究 * 15-EI-0041：参加早期临床试验时患者的期望 * 15-EI-0038： RS1 眼部基因转移治疗 X 连锁视网膜劈裂症的 I/IIa 期研究 * 15-EI-0020：自适应光学视网膜成像 * 14-EI-0173：对 09-M-0198 中登记的有阿尔茨海默病体征和症状的患者的视网膜检查结果进行调查 * 14-EI-0171：黄斑疾病的局灶眼电图 * 14-EI-0108：评估口服米诺环素治疗与视网膜色素变性相关的囊样黄斑水肿的初步研究 * 14-EI-0078：睫状神经营养因子 (CNTF) 治疗 2 型黄斑毛细血管扩张症的 2 期多中心随机临床试验 (MacTel) * 14-EI-0064：全外显子组和全基因组测序用于遗传性和先天性眼部疾病的基因分型 * 13-EI-0154：色觉作为遗传性视网膜变性临床试验的结果衡量标准 * 13-EI-0124：尼替西农治疗 1B 型眼皮肤白化病的初步研究 * 13-EI-0072：微生物组和眼部炎症疾病 * 13-EI-0049：葡萄膜缺损的遗传学 * 12-EI-0203： ABCA4 相关视网膜病变的自然史 * 12-EI-0042： NEI 视网膜疾病壁内生物样本库 * 11-EI-0264：米诺环素作为小胶质细胞抑制剂治疗视网膜中央静脉阻塞的初步研究 * 11-EI-0263：米诺环素作为小胶质细胞抑制剂治疗视网膜分支静脉阻塞的初步研究 * 11-EI-0245：从患有眼病的参与者的体细胞和匹配对照的体细胞中产生诱导多能干 (iPS) 细胞系 * 11-EI-0173：眼移植物抗宿主病的自然史 * 11-EI-0147：年龄相关性黄斑变性参与者暗适应的纵向调查 * 10-EI-0140： Plaquenil 诱导的视网膜毒性患者的基因型-表型研究，以及 ABCA4 基因的评估 * 10-EI-0093：白塞病的免疫遗传学机制 * 10-EI-0016：精神分裂症眼动的内部监测 * 08-EI-0169：患有眼部疾病的潜在研究参与者的评估和治疗方案 * 08-EI-0102：潜在研究参与者评估和诊断的筛选研究 * 08-EI-0099：退行性和炎症性眼部疾病的表观遗传学、分子遗传学和生物标志物 * 08-EI-0043：年龄相关眼病研究 (AREDS) 和 AREDS2 随访 * 08-EI-0031：视觉运动协调 * 06-EI-0236：国家眼科基因分型和表型网络，第一阶段 - 创建遗传性眼科疾病 DNA 存储库 * 06-EI-0068：眼部炎症中的玻璃体蛋白质组和炎症介质 * 06-EI-0059：青光眼及相关疾病家族的临床和分子研究 * 06-EI-0058：近视及相关疾病家庭的临床和分子研究 * 05-EI-0143：视网膜变性的分子遗传学 * 04-EI-0008：角膜营养不良或其他遗传性角膜疾病家族的临床和分子研究 * 03-EI-0123：先天性或遗传性白内障家族的临床和分子研究 * 03-EI-0122：非传染性眼部炎症对不同抗原的免疫反应评估 * 03-EI-0033： X 连锁青少年视网膜劈裂症 - 临床和分子研究 13-EI-0206：自体血清滴眼液治疗造血干细胞移植 (HSCT) 患者严重眼部慢性移植物抗宿主病 (GVHD) 的随机、对照、双盲临床试验 * 13-EI-0102： Gevokizumab 通过 IL-1 抑制治疗活动性巩膜炎 (GATSBY) * 12-EI-0167： NT-501 眼内植入物在 CNGB3 色盲患者中释放睫状神经营养因子 (CNTF) 的 I/II 期研究 * 11-EI-0244：评估右美沙芬作为小胶质细胞抑制剂治疗糖尿病性黄斑水肿 (MiDME2) 的 I/II 期试验研究 * 07-EI-0213：免疫学实验室/国家眼科研究所知识库 * 06-EI-0050：多中心葡萄膜炎类固醇治疗 (MUST) 试验方案 * 05-EI-0096：亚瑟综合症的自然史和遗传学研究