Discussion on the Focus of On-site Inspection of Clinical Trials of Lung Cancer
Targeted Therapy and Immunotherapy Drugs.
10.3779/j.issn.1009-3419.2022.101.32
- Author:
Meng LI
1
;
Lijing XU
1
;
Xiuli LI
1
;
Rong GAO
1
Author Information
1. Center for Food and Drug Inspection of National Medical Products Administration, Beijing 100044, China.
- Publication Type:Journal Article
- Keywords:
Clinical trials;
Immunotherapy;
Lung neoplasms;
New drug research and development;
On-site inspection;
Targeted therapy
- MeSH:
Antineoplastic Agents/therapeutic use*;
Humans;
Immunologic Factors/therapeutic use*;
Immunotherapy;
Lung Neoplasms/drug therapy*;
Molecular Targeted Therapy
- From:
Chinese Journal of Lung Cancer
2022;25(7):506-510
- CountryChina
- Language:Chinese
-
Abstract:
As lung cancer targeted therapy and immunotherapy drugs are the current hot spot in the research and development area of new anti-tumor drugs, the amount of clinical trial in this area is increasing year by year. On the basis of combing the on-site inspections of drug registration clinical trials from 2019 to 2021, combined with the characteristics of lung cancer targeted therapy and immunotherapy drugs, this paper discusses the focus of on-site inspection of clinical trials of such drugs, and puts forward suggestions for the compliant implementation of lung cancer clinical trials.
.
