Current Status and Optimization Strategies for Investigator Initiated Trial on Traditional Chinese Medicine in the Treatment of Malignant Tumors Conducted by Western Medicine Institutions
10.13288/j.11-2166/r.2025.09.002
- VernacularTitle:西医医疗机构开展研究者发起的中医药治疗恶性肿瘤临床研究现状分析及优化实施策略探讨
- Author:
Xuechen GENG
1
;
Yanmei LIU
2
;
Qianqian BU
1
;
Qinchang ZHANG
1
;
Dong ZHANG
1
;
Yuquan TAO
1
;
Liu LI
1
;
Ling LI
2
;
Haibo CHENG
1
Author Information
1. The First Clinical Medical College，Nanjing University of Chinese Medicine，Nanjing，210023
2. Chinese Evidence-based Medicine Center，West China Hospital，Sichuan University
- Publication Type:Journal Article
- Keywords:
investigator initiated trial;
malignant tumors;
integrate traditional Chinese and western medicine;
traditional Chinese medicine clinical trial
- From:
Journal of Traditional Chinese Medicine
2025;66(9):878-882
- CountryChina
- Language:Chinese
-
Abstract:
Investigator initiated trial （IIT） represents a primary format for clinical research in traditional Chinese medicine （TCM）. As key implementation sites for TCM-based IIT targeting malignant tumors， western medicine institutions often face unique challenges in conducting such studies， which limit their feasibility and standardization. This paper reviews the registration status of TCM-based IIT for malignancies conducted in western medical institutions and analyzes key difficulties， including complex project initiation and management processes， limited TCM knowledge and skills among western medicine physicians， and relatively low patient acceptance of TCM. From a practical perspective， the study proposes several optimization strategies. These include improving the review and management mechanisms of TCM-related IIT within western medical institutions， establishing multidisciplinary clinical research teams that integrate TCM and western medicine， and enhancing investigators' training in TCM theory and clinical skills. Additionally， the study suggests standardizing IIT operational procedures， objectifying the collection of TCM diagnostic information， refining subject recruitment methods， and increasing TCM involvement in patient follow-up and management. These investigator-oriented， TCM-featured， and operable strategies aim to promote the high-quality development of TCM-based IIT in western medicine institutions and enhance the clinical application of TCM.
