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

统计设计、监测

基本信息

批准号：
8328400
负责人：
DARBY THOMPSON
金额：
$ 275万
依托单位：
THE EMMES COMPANY, LLC
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-11-01 至 2011-10-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8328400
关键词：
Acquired Immunodeficiency Syndrome Adoption Adrenal Cortex Hormones Adult Adverse effects Affect Age Age related macular degeneration Age-Years Aging Air Air Pressure Allergic Reaction Ambulatory Care Facilities Analytical Chemistry Androgens Angiography Anti-Inflammatory Agents Anti-inflammatory Antibiotics Antigens Appearance Appointments and Schedules Area Area Analyses Ascorbic Acid Audiometry Authorization documentation Autoimmune Diseases Autoimmune Process Avastin Back Background Diabetic Retinopathy Behcet Syndrome Benign Beta Carotene Beverages Bilateral Biological Biological Factors Biological Markers Biological Testing Biopsy Birth Blindness Blood Blood Cells Blood Chemical Analysis Blood Circulation Blood Clot Blood Glucose Blood Pressure Blood Tests Blood Vessels Blood coagulation Blood donor Blood flow Blood specimen Body Fluids Body Weight Bone Density Bone Marrow Brain Caloric Tests Canis familiaris Caring Case-Control Studies Cataract Cell Line Cell physiology Cell surface Cells Chemicals Chemistry Child Chin Cholesterol Choroidal Neovascularization Chronic Cicatrix Clinic Clinic Visits Clinical Clinical Research Clinical Trials Code Collaborations Collecting Cell Collection Coloboma Color Color Visions Complications of Diabetes Mellitus Computers Confocal Microscopy Contact Lenses Contractor Contracts Copper Cornea Corneal Diseases Corneal dystrophy Coughing Crystalline Lens Cysteamine Cystine Cystinosis DNA Dark Adaptation Data Data Analyses Data Collection Data Coordinating Center Data Storage and Retrieval Databases Date of birth Defect Degenerative Disorder Development Devices Dextromethorphan Diabetes Mellitus Diabetic Retinopathy Diagnosis Diagnostic Procedure Diagnostic tests Disease Disease Management Disease Progression Dislocations Docosahexaenoic Acids Documentation Dose Drops Drug Compounding Drug Delivery Systems Drug Formulations Drug Implants Drug Kinetics Drug Stability Drug toxicity Dryness Dyes Ear Early Diagnosis Early treatment Earwax Eating Economics Educational process of instructing Effectiveness Eicosapentaenoic Acid Electrocardiogram Electrodes Electron Microscopy Electroretinography Embryo Enrollment Environment Epidemiology Epigenetic Process Equilibrium Equipment and supply inventories Evaluation Evaluation Studies Event Evoked Potentials External auditory canal Extramural Activities Exudative age-related macular degeneration Eye Eye Development Eye Movements Eye Part Eye diseases Eyedrops Face Family Family Study Family history of Family member Fatigue Fatty Acids Finasteride Fish Oils Florida Flow-It Fluocinolone Acetonide Fluorescein Fluorescein Angiography Folic Acid Food Food, Drug and Cosmetic Act Forehead Frequencies Future Gender Gene Mutation Genealogical Tree Generations Genes Genetic Genetic Polymorphism Genetic Research Genetic screening method Genotype Gland Glare Glaucoma Goggles Gonadal Steroid Hormones Government Growth Growth Factor Hair Hair follicle structure Hand Head Health Health Sciences Healthcare Hearing Hearing Impaired Persons Hearing Tests Height Hemorrhage Hereditary Disease High Pressure Liquid Chromatography Hip region structure Home environment Hormones Hospitals Hour Human Human Resources Human body Hydroxychloroquine Image Immune Immune System Diseases Immune System Part Immune response Immune system Immunization Immunogenetics Immunohistochemistry Immunology Immunosuppressive Agents Implant In Situ Hybridization India Individual Indocyanine Green Infection Infection prevention Inflammation Inflammation Mediators Inflammatory Inherited Injection of therapeutic agent Institutes Institution Institutional Review Boards Instruction Interferon Type II Interferon gamma 1b Intermediate Uveitis Intestines Intramural Research Intravenous infusion procedures Investigation Iris Joints Karyotype Kidney Kidney Diseases Knowledge Label Laboratories Laboratory Animals Labyrinth Laser Surgery Lasers Lead Learning Left Legal Blindness Leucovorin Leukocytes Libraries Life Lifting Light Lighting Liquid substance Live Birth Local Anti-Infective Agents Local anesthesia Location Lucentis Lupus Lutein Lymphocyte Maintenance Male Pattern Baldness Malignant Neoplasms Malignant neoplasm of lung Manuals Manuscripts Marketing Maryland Measurement Measures Medical Medical History Medical Imaging Medicare Medicine Membrane Metabolic Diseases Metals Methods Methotrexate Microglia Microscope Minocycline Mitochondria Modems Molecular Molecular Biology Molecular Genetics Monitor Monkeys Monoclonal Antibodies Movement Mucous Membrane Muscle Muscle Weakness Mydriasis Myopia National Eye Institute National Heart, Lung, and Blood Institute Nationalities Natural History Nature Neck Needles Neuraxis Non-Hodgkin&apos s Lymphoma Normal tissue morphology Nutrient Ointments Omega-3 Fatty Acids Operative Surgical Procedures Ophthalmic examination and evaluation Ophthalmologic Surgical Procedures Ophthalmologist Ophthalmoscopes Optic Nerve Optical Coherence Tomography Optics Oral Oral cavity Oranges Oregon Organ Organelles Oryctolagus cuniculus Otoscopes Outcomes Research Outpatients Oxides Pain Painless Pakistan Panuveitis Paper Participant Patient Monitoring Patient Recruitments Patients Patients&apos Rooms Pattern Peptides Persons Pharmaceutical Preparations Pharmacy facility Phase Phenotype Photography Physical Examination Physicians Physiological Pilot Projects Placebos Play Polymerase Chain Reaction Polyunsaturated Fatty Acids Population Population Study Populations at Risk Positioning Attribute Posterior Uveitis Preclinical Testing Prednisone Pregnancy Tests Premature Ovarian Failure Preparation Principal Investigator Procedures Process Production Protein Fragment Proteins Proteome Protocols documentation Pupil Quality of life Quality-of-Life Assessment Questionnaires Randomized Reading Recommendation Recording of previous events Records Recruitment Activity Regimen Renal function Reporting Reproducibility Research Research Design Research Personnel Resources Rest Retina Retinal Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Retinitis Pigmentosa Review Committee Rheumatoid Arthritis Risk Roentgen Rays Role Safety Sampling Sampling Studies Scanning Schedule Schizophrenia Screening procedure Secondary to Secure Series Serous Services Severities Signal Transduction Silver Single Nucleotide Polymorphism Sirolimus Site Skin Smoke Somatic Cell Source Specialist Specific qualifier value Specimen Speech Speed Spottings Staging Stem cell transplant Stem cells Sterility Steroids Stomach Strabismus Stream Structure Sunlight Surface Swab Swelling Switzerland Symptoms System Tablets Techniques Telephone Tennessee Test Result Testing Testosterone Texas Therapeutic immunosuppression Thick Thoracic Radiography Thyroid Gland Time Tissues Toxic effect Trademark Training Transplantation Travel Treatment Effectiveness Treatment Protocols Tube Turner&apos s Syndrome Ultrasonography Ultraviolet Rays United States United States Food and Drug Administration United States National Institutes of Health Universities Upper arm Urine Use Effectiveness Usher Syndrome Uveitis Validation Vascular Endothelial Growth Factors Vascular blood supply Veins Vertebral column Vision Vision Disorders Vision Tests Visit Visual Visual Acuity Visual Motor Coordinations Visually Impaired Persons Vitamin E Vitamin K Vitamins Vitelliform macular dystrophy Walking Water Weight Weights and Measures West Virginia Woman Work X Chromosome X-Linked Retinoschisis Zinc Zinc Oxide age group age related arm autoimmune uveitis base bevacizumab bone cellular targeting central retinal vein occlusion checkup examination chemokine clinical epidemiology computerized computerized data processing congenital cataract cost effectiveness cytokine data management deafness design diabetic diabetic patient diagnosis evaluation diaries digital imaging disease-causing mutation drug distribution drug standard effective therapy efficacy testing evaluation/testing experience eye blood vessel eye dryness fatherhood fighting follow-up gastrointestinal gene function gene therapy genetic risk factor geographic atrophy graft vs host disease healthy volunteer hearing impairment hip bone human FRAP1 protein immunopathology improved induced pluripotent stem cell inhibitor/antagonist instrument interest irritation lacrimal lens light microscopy liver function macula macular edema male medical schools meetings middle ear milliliter molecular pathology monitoring device new growth novel novel therapeutics operation optic nerve disorder oral tolerance patient safety peripheral blood pill preclinical study pregnant pressure prevent programs prostate enlargement protocol development psychologic randomized trial ranibizumab repository research study response rituximab safety testing sample collection sound stability testing standard care standard of care sugar sunglasses trait treatment effect treatment trial tumor validation studies volunteer working group zeaxanthin

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.

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。