Clinical trial design and implementation of research and implementation of new TCM clinical trials b

China's pharmaceutical sources are growing, combining the wisdom of traditional medicine, and their rational use is highly beneficial for healthy nutrition. This paper system reviews the development history of China's new TCM drug clinical trials and identifies key issues. It proposes that under TCM's 3-compound regulatory review evidence system, clinical trials of new TCM drugs should take full advantage of human use experience, follow a clinical value-oriented pathway, and choose clinical development pathways flexibly without having to follow traditional phases and submodels.

In order to clarify the clinical advantages of a prescription based on human-use experience data, the test target should be determined by identifying the clinical location, and the risk-benefit assessment should be carried out to support the design of subsequent clinical trials. At the same time, following the basic principles of clinical trials, new design methodologies should be introduced, including the use of adaptive design to achieve seamless phases Ⅱ and Ⅲ; integration; analysis of human use experience data to identify advantageous patient populations, providing a scientific basis for the selection of patient populations and the development of clinical trial protocols It should be noted that the above content is based on international public research findings and is for reference in HealthCop and does not constitute a clinical recommendation. If you have any health questions, please consult professional medical personnel.