US-China-Japan Research Consortium on Herbal Medicines

描述（由申请人提供）：该计划赠款的长期目标是建立一个国际CAM研究中心，重点是对东亚草药进行系统评价。该项目为未来（第二阶段）NIH申请建立CAM国际研究中心提供了技术、管理和科学基础。我们的目标是建立一个正式的合作伙伴关系，包括来自哈佛医学院，中国中医药研究院，香港中文大学和庆应义塾大学（日本）的研究人员，共同确定和优先考虑有前途的草药，可以系统地采购，提取，表征和临床前（和临床）环境测试。来自4个参与机构的主要专家将通过互联网电话会议软件（和2次面对面会议）定期会面，以审查和优先考虑值得进一步研究的候选草药。将根据预定方案提取选择用于评价的植物材料。将在哈佛医学院现有的NIH赞助的设施和香港中文大学的实验室中，在各种生物测定中对粗提物、选定的馏分以及纯化合物进行高通量筛选。将对具有相关生物活性的馏分和化合物进行二次生物测定，并尽可能确定其分子结构。将进一步研究具有生物活性的级分和化合物是否存在涉及来自单一植物或来自植物的复杂混合物的多种化合物/级分的协同作用。只有那些被证明具有显著生物活性的草药才能继续在人体试验中进行进一步研究。鉴定可重复的、具有生物活性的组分和化合物，以及重新确定优先顺序的候选草药清单，将是该计划拨款的主要交付成果。此外，合作研究者将讨论后续多中心临床试验的实施策略，这些临床试验遵循NIH临床研究标准。他们将谈判一项正式的合作协议，该协议将圆满解决知识产权、版税分享、出版程序和共享NIH资源等问题。将从参与机构和一名国际法顾问那里获得法律的专门知识和建议。合作研究者将制定正式的培训计划和参与研究中心之间的学术交流计划。最后，我们将确定，作为该规划补助金的一部分，合作机构的理想数量（2，3或4），预计申请该NIH国际CAM研究中心的第二阶段。

DESCRIPTION (provided by applicant): This planning grant has the long-term goal of developing an International Center for CAM Research focused on the systematic evaluation of East Asian herbal medicines. This project provides the technical, administrative and scientific bases of a future (Phase II) NIH application for an International Center for Research on CAM. Our objective is to develop a formal collaborative partnership involving investigators from the Harvard Medical School, the China Academy of Traditional Chinese Medicine, the Chinese University of Hong Kong, and Keio University (Japan) to jointly identify and prioritize promising herbal medicines, which can be systematically procured, extracted, characterized and tested in preclinical (and clinical) settings. Leading experts from the 4 participating institutions will meet regularly via Internet teleconferencing software (and 2 face-to-face meetings) to review and prioritize herbal medicine candidates worthy of further investigation. Plant materials selected for evaluation will be extracted according to predetermined protocols. Crude extracts, selected fractions as well as pure compounds will be subjected to High Throughput Screening in a wide variety of bioassays at an existing NIH-sponsored facility at Harvard Medical School and in laboratories at the Chinese University of Hong Kong. Those fractions and compounds with biological activity of interest will undergo secondary bioassays and, wherever possible, their molecular structure will be determined. Fractions and compounds with biological activity will be further investigated for the presence of synergy involving multiple compounds/fractions from single plants or from complex mixtures of plants. Only those herbal medicines shown to have significant biological activity will remain candidates for further investigation in human trials. The identification of reproducible, biologically active fractions and compounds and a reprioritized list of candidate herbal medicines will be the principal deliverable of this planning grant. In addition, co-investigators will discuss strategies for the implementation of subsequent multi-site clinical trials which adhere to NIH standards for clinical research. They will negotiate a formal collaboration agreement which satisfactorily addresses issues of intellectual property, royalty sharing, publication procedures and shared access to NIH resources. Legal expertise and recommendations from participating institutions and a consultant in International Law will be obtained. Co-investigators will develop formal plans for training programs and scholarly exchange between participating research sites. Lastly, we will determine, as part of this planning grant, the ideal number of partnering institutions (2, 3 or 4) in anticipation of an application for Phase II of this NIH International Center for Research on CAM.