Emory University PD Neuroprotection Clinical Trial Center

埃默里大学 PD 神经保护临床试验中心

• 批准号: 7760093
• 负责人: JORGE L JUNCOS
• 金额: $ 8.04万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-17 至 2012-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7760093
• 关键词: Agreement; Alabama; American; Area; Certification; Characteristics; Clinical Practice Guideline; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Conduct Clinical Trials; Confidentiality; Contracts; Data; Data Collection; Diagnosis; Disease Association; Disease Progression; Documentation; Double-Blind Method; Futility; Goals; Good Clinical Practice; Monitoring Clinical Trials; Movement Disorders; Newly Diagnosed; Parkinson Disease; Participant; Patients; Persons; Pharmaceutical Preparations; Phase III Clinical Trials; Pilot Projects; Population Heterogeneity; Population Study; Principal Investigator; Process; Randomized; Recruitment Activity; Research; Research Ethics Committees; Research Infrastructure; Research Personnel; Resources; Safety; Series; Site; Specimen; Testing; Training; United States National Institutes of Health; Universities; Work; experience; neuroprotection; programs

The Emory University Movement Disorders Program and the Comprehensive Parkinson's Disease Center has proven to have in place the necessary resources and infrastructure to continue to be a Parkinson's Disease Neuroprotection Clinical Trial Center. We have experience in conducting neuroprotective trials and are in fact already participating in the NET-PD Futility Study 2 trial as a subcontractor to University of Alababa in Birmingham (UAB). The aim of this proposal in to revert our center from a subcontracting site to its original status as an independent site. We have been a successful site in this and many other studies in part because of the estimated 50,000 persons currently diagnosed with Parkinson's disease in our region and the estimated 5,000 patients that are newly diagnosed each year in our region. The demographic characteristics of the area served by Emory University allows for the recruitment of an ethnically diverse population of study patients. The Emory University programs involved in the research and treatment of Parkinson's Disease have the necessary space to comfortably and efficiently conduct clinical trials, prepare and process lab specimens and securely and confidentially maintain study medication and documentation. An experienced clinical trial team is currently in place to assure that the studies are conducted in a manner which allows for the accurate, efficient and timely collection of data. The Clinical Trial Staff have all received training and certification to conduct clinical trials from the Emory University Institutional Review Board and have been trained and currently follow Good Clinical Practice Guidelines to assure the safety and protection of study participants. The Principal Investigator, Dr. Jorge L. Juncos, has extensive experience in developing, conducting and monitoring clinical trials and an excellent track record in the recuitment of patients. The Center currently works closely with the American Parkinson Disease Association of Georgia to inform and recruit new patients for these studies. In conclusion this proposal should evidence the fact that our center has demonstrated is capacity for serving as an excellent investigative and recruitment site for these NIH sponsored trials in neuroprotection in PD.

埃默里大学运动障碍项目和综合帕金森病中心 已被证明有必要的资源和基础设施，继续成为帕金森氏症 疾病神经保护临床试验中心。我们有进行神经保护试验的经验， 事实上，已经作为分包商参加了NET-PD无效性研究2试验， 伯明翰（Birmingham）该提案的目的是将我们的中心从分包地点恢复到 它作为一个独立网站的原始状态。我们一直是一个成功的网站在这方面和许多其他研究， 部分原因是我们地区目前估计有5万人被诊断患有帕金森病 以及我们地区每年新诊断的大约5,000名患者。人口 埃默里大学所服务的地区的特点允许招聘一个种族多样的 研究患者人群。埃默里大学的项目涉及研究和治疗 帕金森病患者有必要的空间舒适和有效地进行临床试验，准备 处理实验室标本，安全保密地保存研究药物和文件。 一个经验丰富的临床试验团队目前已经到位，以确保研究的方式进行， 这使得能够准确、有效和及时地收集数据。临床试验工作人员均已收到 埃默里大学机构审查委员会进行临床试验的培训和认证， 已接受培训，目前遵循药物临床试验质量管理规范指南，以确保安全性和保护 的研究参与者。首席研究员Jorge L.容科斯，拥有丰富的 开发、开展和监测临床试验，并在以下方面有良好的记录： 患者该中心目前与格鲁吉亚的美国帕金森病协会密切合作， 为这些研究提供信息并招募新患者。总之，这一建议应证明这样一个事实， 我们的中心已经证明是作为一个优秀的调查和招聘网站， 这些NIH赞助的帕金森病神经保护试验。