US-China-Japan Research Consortium on Herbal Medicines

描述（由申请人提供）：该计划资助的长期目标是建立一个国际CAM研究中心，专注于东亚草药的系统评价。该项目为未来（第二阶段）NIH申请CAM国际研究中心提供了技术、行政和科学基础。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、中国中医科学院、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，这些草药可以系统地采购、提取、表征和在临床前（和临床）环境中进行测试。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定期举行会议（以及2次面对面会议），以审查和优先考虑值得进一步研究的候选草药。选择用于评估的植物材料将按照预定的方案提取。粗提取物、精选馏分以及纯化合物将在美国国立卫生研究院资助的哈佛医学院现有设施和香港中文大学的实验室中进行各种生物测定的高通量筛选。那些具有感兴趣的生物活性的组分和化合物将进行二次生物测定，并在可能的情况下确定其分子结构。具有生物活性的组分和化合物将进一步研究是否存在来自单一植物或来自复杂植物混合物的多种化合物/组分的协同作用。只有那些显示出具有显著生物活性的草药才会继续在人体试验中进行进一步研究。可重复的生物活性组分和化合物的鉴定以及候选草药的重新排序清单将是该计划拨款的主要交付成果。此外，共同研究人员将讨论后续多地点临床试验的实施策略，这些临床试验遵循NIH的临床研究标准。他们将协商一份正式的合作协议，该协议将令人满意地解决知识产权、版税分享、出版程序和共享NIH资源等问题。将获得参加机构和一名国际法顾问的法律专门知识和建议。共同研究人员将制定正式的培训计划和参与研究地点之间的学术交流计划。最后，作为计划拨款的一部分，我们将确定合作机构的理想数量（2、3或4），以预期NIH国际CAM研究中心第二阶段的申请。

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.