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

描述（由申请人提供）：本项目旨在建立美国-印度帕金森病合作伙伴关系（CPPD）. CPPD将依靠两个已建立的科学研究者联盟的共同努力，美国的帕金森研究小组（PSG）和印度的帕金森研究联盟（PRAI），每个联盟都致力于合作规划，实施，分析和报告帕金森病的对照临床试验 （PD）。PSG已经存在了二十多年，已经建立了有效设计、实施、招募受试者和发布PD临床研究结果的基础设施。PRAI的建立在印度主要地理区域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PD试验受试者。将这两种能力结合在一起将进一步加强两国的最终目标，即找到有效治疗帕金森病的方法。CPPD将制定政策和程序，以符合两国的监管要求;创建系统和流程，以在美国和印度之间分配研究药物和转移人体样本;并将在相关评级量表，良好临床实践和使用法规方面对两国的研究人员进行培训。

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.