Current situation analysis and countermeasures of human experience collection of traditional Chinese medicine in medical institutions
In order to establish a technical evaluation system in line with the characteristics of traditional Chinese medicine(TCM)and promote the inheritance and innovative development of TCM,China is building a TCM registration and evaluation evidence system combining TCM theory,human experience,and clinical trials.Human experience is of great significance to support the registration and evaluation of new drugs of TCM.Based on the survey of 20 medical institutions in Shanghai,this paper analyzed the current situation and common problems of human experience collection of TCM.It was found that medical institutions had been aware of carrying out human experience collection for the development of TCM preparations or new drugs.However,the hardware conditions,personnel capabilities,and the importance of medical institutions in collecting human experience were still not optimistic.There were difficulties in the collection process.90%of institutions believed that the quality of collected data did not meet the requirements of drug registration.Regulators and medical institutions should work together to improve and standardize the collection of human experience of TCM by improving collection methods,increasing research capabilities,strengthening the construction of information systems,and enhancing research quality management according to GCP principles,so as to ultimately obtain high-quality evidence materials to support the innovation and transformation of TCM.
medical institutiontraditional Chinese medicinehuman experienceresearch and analysis