浅析“三结合”审评证据体系对中药新药转化的作用

为了体现中药的特点和优势,国家层面提出“构建中医药理论、人用经验和临床试验相结合的审评证据体系” 的要求,不仅尊重中药研发规律和实际,中医药理论的传承创新、人用经验的规范收集整理和临床试验的精准设计也有助于基于临床价值产生有效的中药新方,优化研发策略、缩短研发周期、降低研发风险、提高研发效率,通过提高中药新药研发的成功率,解决目前我国中医药科技成果转化率不足的问题。基于“三结合”的成果转化模式,医疗机构亦能够不断提高中药新药的原始创新能力、临床研发水平和科技服务能力,是政策引导研发实践、促进中药新药转化的重要路径之一。

Analysis on the effects of the "three combined" evaluation evidence system on the transformation of traditional Chinese medicine new drugs

To reflect the characteristics and advantages of Chinese medicine, the national level has proposed to build a evaluation evidence system, that combines Chinese medicine theory, human used experience and clinical trials. This evaluation evidence system not only respects the rules and practice of the research and development (R&D) of TCM new drugs, the inheritance and innovation of TCM theory, the standardized collection and arrangement of human used experience, and the precise design of clinical trials but also helps to generate effective new TCM formulas based on clinical value, optimize the R&D strategies, shorten R&D cycles, reduce R&D risks, and improve the R&D efficiency. The evaluation evidence system has improved the success rate of new drug development in Chinese medicine and solved the problem of insufficient transformation rate of scientific and technological. Based on the "three combined" review evidence system to achieve TCM new drugs transformation, medical institutions can also continuously improve the original innovation ability, clinical R&D level and scientific and technological service ability of TCM new drugs. This model is one of the important paths to promote the transformation of TCM new drugs under policy guidance.