新药研发风险管理的国内研究现状

目的：为进行新药研发的医药科研人员、相关管理人员、医药高等院校研究人员提供新药研发资料，以期更好地指导新药研发，降低研发风险。方法：采用文献研究法，查阅了近15年公开发表的有关新药研发风险管理方面的研究成果。结果：将风险管理理论与新药研发相结合，已成为医药研发相关人员共同关注的热点问题，众多专家、学者从不同方面、不同层次进行了探讨。主要包括：新药研发风险类型的研究，降低和规避新药研发风险的研究，新药研发风险评估和研发项目风险评价指标体系的研究，以及针对新药研发某一特定风险的研究等。结论：我国对新药研发风险及风险的管理已经有了一定认识，但从总体看还仅仅表现在意识层面，相关研究成果较为笼统、分散，水平有待提高；这种情况在中药新药研究中表现得更为明显，专门针对中药新药研发风险管理的研究成果不仅数量少，且研究层次也不够系统和深入。

Current Status of Risk Management of New Drug R&D in China

Objective: To provide data for the new drug R&D medical researchers, relevant management personnel and medical colleges and universities staff so as to better guide the new drugs R&D and reduce the development risk. Methods: The research achievements of risk management of new drug R&D published in recent 15 years were reviewed. Resuults: The combination of risk management theory with new drug R&D has become a hot issue for medical researchers. Many experts and scholars have discussed from different aspects and at different levels, such as types of the risk of new drug R&D, the way to reduce and avoid the risk of new drug R&D, risk assessment of new drug R&D, risk evaluation index system of new drug R&D, as well as some specifc risks of new drug R&D. Conclusion: At present, there is a certain degree of understanding of the risk and risk management of new drug R&D in our country. But in general, it only exists in consciousness and the relevant research results are relatively general, scattered, and the research needs to be improved as well. It is more obvious in the research of new drugs of traditional Chinese medicine (TCM). Not only is the number of research achievements specifically for risk management of new drug R&D of TCM small, but also the research is not systematic and profound enough.