Application of real world study and human use experience in research and development of new traditional Chinese medicine drugs.
10.19540/j.cnki.cjcmm.20210517.501
- Author:
Zhong-Qi YANG
1
;
Hui-Min TANG
1
;
Ya-Qin TANG
1
;
Yan-Ping DU
1
;
Rui GAO
2
;
Si-Yuan HU
3
;
Wei-An YUAN
4
;
Chong ZOU
5
;
Hong DING
6
;
Yan-Ling ZHAO
7
Author Information
1. the First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou 510407, China.
2. Xiyuan Hospital, China Academy of Chinese Medical Sciences Beijing 100091, China.
3. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300381, China.
4. Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Shanghai 200021, China.
5. Jiangsu Province Hospital of Chinese Medicine Nanjing 210029, China.
6. Affiliated Hospital of Chengdu University of Traditional Chinese Medicine Chengdu 610072, China.
7. the First Hospital of Hunan University of Chinese Medicine Changsha 410007, China.
- Publication Type:Journal Article
- Keywords:
human use experience;
new traditional Chinese medicine(TCM) drug;
real world study(RWS)
- MeSH:
Drugs, Chinese Herbal/adverse effects*;
Humans;
Medicine, Chinese Traditional;
Prescriptions;
Reproducibility of Results;
Research
- From:
China Journal of Chinese Materia Medica
2021;46(22):5987-5991
- CountryChina
- Language:Chinese
-
Abstract:
Real world study(RWS) refers to the process of collecting real world data related to the health of research subjects in the real world environment for pre-set clinical problems and obtaining the status of drug use and potential benefits/risks through analysis. The data are derived from the hospital information system(HIS), medical insurance system, disease registration system, adverse drug reaction monitoring system, etc. Human use experience of traditional Chinese medicine(TCM) is a new concept put forward by experts after summarizing the problems existing in clinical trials of new TCM drugs. The data come partially from the real world, and more importantly, such key elements as the formulated prescriptions of new TCM drugs, principles and methods, and clinical applications should be covered. RWS is mainly used for adverse drug reaction monitoring after marketing, benefit evaluation of listed drugs, decision-making of medical treatment and medical insurance, as well as supervision and approval of special medical devices and special drugs. It is complementary to randomized controlled clinical trials. Human use experience is suitable for the research and development of Chinese medicinal compound preparations and the expansion of functions and indications. There are no special provisions for clinical indications and target population. There exists a sequential relationship between the human use experience and clinical trials. Specifi-cally, the summarization of human use experience provides good support for the design and implementation of clinical trials, which is an important segment in the research and development of new TCM drugs. The correlation between real-world data and research results and their reliability should be ensured in RWS, and the unreality should be avoided. The key to summarizing the human use experience is to identify the clinical orientation, target population, course of treatment, usage and dosage of new TCM drugs, and it should be noted that human use experience does not only mean clinical experience. Experimental clinical trial(PCT), a type of study in the real world, has been commonly employed for the summary of human use experience. RWS and human use experience are different research designs targeting different clinical questions in the research and development of new TCM drugs, which can be flexibly selected depending on the actual situation.
