Consensus on collaborative ethical review of multi-center clinical trials of new drugs of traditional Chinese medicine (version 1.0).
10.19540/j.cnki.cjcmm.20210304.501
- Author:
Chong ZOU
1
;
Hong DING
2
;
Rui GAO
3
;
Si-Yuan HU
4
;
Jian-Zhong LIU
5
;
Bo LI
6
;
Xiao-Hui LI
7
;
Ding-Ju PAN
8
;
Jian-Yuan TANG
2
;
Xiao-Yun TONG
9
;
Ju-Yong WANG
10
;
Wei-An YUAN
11
;
Xun ZHANG
12
;
Miao ZHANG
13
;
Yan-Ling ZHAO
14
;
Zhong-Qi YANG
15
Author Information
1. Jiangsu Provincial Hospital of Traditional Chinese Medicine Nanjing 210029, China.
2. Hospital of Chengdu University of Traditional Chinese Medicine Chengdu 610075, China.
3. Xiyuan Hospital, China Academy of Chinese Medical Sciences Beijing 100091, China.
4. the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300192,China.
5. Hubei Hospital of Traditional Chinese Medicine Wuhan 430061, China.
6. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University/Beijing Institute of Traditional Chinese Medicine Beijing 100010, China.
7. Xiamen Hospital of Traditional Chinese Medicine Xiamen 361001, China.
8. the First Affiliated Hospital of Guizhou University of Chinese Medicine Guiyang 550001, China.
9. Yunnan Hospital of Traditional Chinese Medicine Kunming 650021, China.
10. Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Shanghai 200032,China.
11. Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
12. Guangdong Hospital of Traditional Chinese Medicine Guangzhou 510120, China.
13. the Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine Harbin 150001, China.
14. the First Affiliated Hospital of Hunan University of Chinese Medicine Changsha 410000, China.
15. the First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou 510407, China.
- Publication Type:Journal Article
- Keywords:
center ethics committee;
collaborative;
multi-center clinical trial;
new drugs of traditional Chinese medicine
- MeSH:
Biomedical Research;
Clinical Trials as Topic;
Consensus;
Drugs, Chinese Herbal;
Ethical Review;
Humans;
Medicine, Chinese Traditional;
Multicenter Studies as Topic;
Pharmaceutical Preparations
- From:
China Journal of Chinese Materia Medica
2021;46(7):1696-1700
- CountryChina
- Language:Chinese
-
Abstract:
At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.
