Research on the current status of clinical trial supervision for tumor neoantigen vaccine in China
- VernacularTitle:我国肿瘤新生抗原疫苗临床试验监管现状研究
- Author:
Qiang LIU
1
;
Mengqing LU
2
;
Hongguo HU
3
;
Liangjiang CHEN
1
;
Wenbing YAO
1
Author Information
1. School of International Pharmaceutical Business/Key Laboratory for Drug Supervision Innovation and Evaluation of National Medical Products Administration，China Pharmaceutical University，Nanjing 211198，China
2. Shenzhen Health Development Research and Data Management Center，Guangdong Shenzhen 518000，China
3. Chongqing Yaopharma Co.，Ltd.，Chongqing 401121，China
- Publication Type:Journal Article
- Keywords:
tumor neoantigen vaccine;
clinical trial;
supervision model;
current status of supervision
- From:
China Pharmacy
2022;33(23):2826-2830
- CountryChina
- Language:Chinese
-
Abstract:
Based on the current laws and regulations framework of China， combined with practical cases， this paper systematically and comprehensively analyzes the supervision attributes， clinical trial supervision model and existing problems of tumor neoantigen vaccine， aiming to provide reference for the construction of the supervision system of clinical trial of tumor neoantigen vaccine in China. The results showed that， at present， the clinical trials of tumor neoantigen vaccine in China adopt a dual-track supervision model： clinical trials initiated by pharmaceutical enterprises and clinical trials initiated by researchers. This supervision model lags behind the development speed of the industry， mainly in the following aspects： challenges brought by dual- track supervision； the clinical trial data initiated by researchers are not effectively connected with new drug research applications； the guiding principles of clinical trial supervision need to be improved. Relevant medical institutions， regulatory authorities and cooperative enterprises can help the development of the regulatory system for clinical trials of tumor neoantigen vaccine in China from the above aspects.
