US-China-Japan Research Consortium on Herbal Medicines

描述(由申请者提供)：这笔规划赠款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估。该项目为美国国立卫生研究院未来(第二阶段)申请国际计算机辅助制造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、中国中医学院、香港中文大学和日本庆应大学的研究人员，共同识别和优先考虑有希望的草药，这些草药可以在临床前(和临床)环境中系统地采购、提取、表征和测试。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开会(和2个面对面的会议)，审查和优先考虑值得进一步研究的草药候选。选择用于评估的植物材料将根据预定的方案进行提取。粗提物、精选部分以及纯化合物将在哈佛医学院NIH赞助的现有设施和香港中文大学的实验室进行各种生物分析的高通量筛选。那些具有生物活性的组分和化合物将接受二次生物分析，并在可能的情况下确定其分子结构。将进一步研究具有生物活性的馏分和化合物是否存在协同作用，包括来自单一植物或来自复杂植物混合物的多种化合物/馏分。只有那些被证明具有显著生物活性的草药仍将是人体试验中进一步研究的候选药物。确定可复制的、具有生物活性的部分和化合物以及重新排序的候选草药清单将是这项规划赠款的主要交付成果。此外，联合调查员还将讨论实施符合美国国立卫生研究院临床研究标准的后续多点临床试验的策略。他们将谈判一项正式的合作协议，该协议令人满意地解决了知识产权、版税分享、出版程序和共享NIH资源访问等问题。将从参与机构和一名国际法顾问那里获得法律专门知识和建议。联合调查人员将为参与研究地点之间的培训计划和学术交流制定正式计划。最后，作为规划拨款的一部分，我们将确定理想的合作机构数量(2、3或4个)，以期申请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.