Emory University PD Neuroprotection Clinical Trial Center

描述(由申请人提供)：埃默里大学运动障碍项目和帕金森氏病综合中心已被证明拥有必要的资源和基础设施，可以继续成为帕金森氏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，实际上已经作为阿拉巴马大学伯明翰分包商参与了Net-PD无效性研究2试验。这项提议的目的是将我们的中心从一个转包地点恢复到其作为独立地点的原始状态。我们在这项研究和许多其他研究中取得了成功，部分原因是我们地区目前估计有50,000人被诊断为帕金森氏症，我们地区每年估计有5,000名新诊断患者。埃默里大学服务的地区的人口统计特征允许招募不同种族的研究患者。参与帕金森氏症研究和治疗的埃默里大学项目拥有必要的空间，可以舒适有效地进行临床试验，准备和处理实验室标本，并安全和保密地维护研究药物和文件。一支经验丰富的临床试验团队目前已就位，以确保研究以允许准确、高效和及时收集数据的方式进行。临床试验工作人员都接受了埃默里大学机构审查委员会提供的进行临床试验的培训和认证，并已接受培训，目前遵循良好的临床实践指南，以确保研究参与者的安全和保护。首席研究员Jorge L.Juncos博士在开发、进行和监测临床试验方面拥有丰富的经验，在招募患者方面有着出色的记录。该中心目前与美国佐治亚州帕金森病协会密切合作，为这些研究通知和招募新患者。总之，这项建议应该证明，我们的中心已经证明了我们有能力为这些NIH赞助的帕金森氏症神经保护试验提供良好的研究和招募地点。

DESCRIPTION (provided by applicant): 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 Alabama 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 recruitment 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.