Key points for ethical review of investigator-initiated clinical trials on traditional Chinese medicine
10.12026/j.issn.1001-8565.2025.01.08
- VernacularTitle:研究者发起的中医药临床研究伦理审查要点
- Author:
Jing WANG
1
Author Information
1. Office of Ethics Committee， Beijing Hospital of Traditional Chinese Medicine， Capital Medical University， Beijing 100010， China
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine;
investigator-initiated clinical trial;
ethical review
- From:
Chinese Medical Ethics
2025;38(1):52-57
- CountryChina
- Language:Chinese
-
Abstract:
The academic development of traditional Chinese medicine （TCM） originates from numerous clinical practices. The efficacy of TCM， its mechanism of action， and the unique value of TCM have been verified through clinical research， contributing to TCM’s inheritance and development. At present， there is an increasing number of investigator-initiated clinical trials （IIT）. The IIT projects involving TCM intervention have different designs in terms of basic theory， syndrome differentiation， prescription composition， dosage form， dosage， and other aspects， as well as even posing challenges to the project review of the ethics committee. The basic ethical principles followed by clinical research institutions of modern medicine and TCM are consistent. The ethical review of the IIT projects involving TCM intervention needs to reflect the development laws of TCM itself， as well as conform to the characteristics of TCM and the laws of new drug research and development. TCM medical institutions need to combine their professional characteristics， sort out clinical experience， guide researchers to conduct clinical research on TCM in an orderly manner with a patient-centered and clinical value-oriented， verify the clinical value of TCM’s new drugs， and improve the success rate of translating the results of TCM’s new drugs.
