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综合帕金森病中心已被证明拥有必要的资源和基础设施，继续成为帕金森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，我们已经作为伯明翰亚拉巴马大学（UAB）的分包商参与了NET-PD无效性研究2试验。该提案的目的是将我们的中心从分包站点恢复到其作为独立站点的原始状态。我们在这项研究和许多其他研究中一直是一个成功的网站，部分原因是我们地区目前估计有50 000人被诊断患有帕金森病，我们地区每年估计有5 000名新诊断的患者。埃默里大学所服务地区的人口统计学特征允许招募不同种族的研究患者人群。参与帕金森病研究和治疗的埃默里大学项目有必要的空间来舒适有效地进行临床试验，准备和处理实验室标本，并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，以确保研究的进行方式能够准确，有效和及时地收集数据。临床试验工作人员均接受了Emory大学机构审查委员会的临床试验培训和认证，并接受了培训，目前遵循药物临床试验质量管理规范指南，以确保研究参与者的安全和保护。首席研究员Jorge L.容科斯在开发、实施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，该提案应证明我们的中心已证明有能力作为NIH申办的PD神经保护试验的优秀研究和招募中心。

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.