U.S. India Collaborative Partnership in Parkinson Disease (CPPD)

描述(由申请者提供)：该项目旨在建立美印帕金森病合作伙伴关系(CPPD)。帕金森病研究中心将依靠美国帕金森研究小组(PSG)和印度帕金森研究联盟(PRAI)这两个成熟的科学研究财团的共同努力，每个财团都致力于帕金森病受控临床试验的合作规划、实施、分析和报告 (Pd)。PSG已经存在了20多年，拥有成熟的基础设施，可以有效地设计、实施、招募受试者并发布PD临床研究的结果。PRAI的建立在印度各地的主要地理位置建立了一个由经验丰富的临床医生和研究人员组成的网络，以有效和高效地进行PD研究，并能够快速招募受试者进行PD试验。将这两种能力结合在一起将进一步加强两国找到有效治疗帕金森病的最终目标。CPPD将制定政策和程序，以遵守两国的监管要求；创建在美国和印度之间分发研究药物和转移人体样本的系统和程序；并将就相关评级标准、良好临床实践和符合监管规定的数据管理系统的使用对两国的研究人员进行培训，以便未来PD的临床试验可以在美国和印度无缝进行。

DESCRIPTION (provided by applicant): This project is to establish a US - India Collaborative Partnership in Parkinson Disease (CPPD). The CPPD will rely upon the combined efforts of two established consortia of scientific investigators, the Parkinson Study Group (PSG) in the US, and the Parkinson Research Alliance of India (PRAI), each of which is committed to cooperative planning, implementation, analysis and reporting of controlled clinical trials in Parkinson Disease (PD). The PSG, in existence for over two decades, has an established infrastructure to effectively design, implement, recruit subjects, and publish results for clinical research in PD. The establishment of PRAI created a network of experienced clinicians and researchers in major geographic locales throughout India to effectively and efficiently conduct PD research, with the added benefit of being able to quickly recruit subjects for PD trials. Bringing these two capabilities together will further enhance the ultimate goals of both countries to find effective treatment for Parkinson Disease. The CPPD will establish policies and procedures to comply with regulatory requirements in both countries; create systems and processes to distribute study drug and transfer human samples between US and India; and will train investigators in both countries on pertinent rating scales, Good Clinical Practices, and use of regulatory-compliant data management systems, so that future clinical trials in PD can be conducted seamlessly across the US and India.