Discussion on the Focus of On-site Inspection of Clinical Trials of Lung Cancer  Targeted Therapy and Immunotherapy Drugs

Meng LI; Lijing XU; Xiuli LI; Rong GAO

doi:10.3779/j.issn.1009-3419.2022.101.32

Chinese Journal of Lung Cancer (Jul 2022)

Discussion on the Focus of On-site Inspection of Clinical Trials of Lung Cancer  Targeted Therapy and Immunotherapy Drugs

Meng LI,
Lijing XU,
Xiuli LI,
Rong GAO

Affiliations

Meng LI: Center for Food and Drug Inspection of National Medical Products Administration, Beijing 100044, China
Lijing XU: Center for Food and Drug Inspection of National Medical Products Administration, Beijing 100044, China
Xiuli LI: Center for Food and Drug Inspection of National Medical Products Administration, Beijing 100044, China
Rong GAO: Center for Food and Drug Inspection of National Medical Products Administration, Beijing 100044, China

DOI: https://doi.org/10.3779/j.issn.1009-3419.2022.101.32
Journal volume & issue: Vol. 25, no. 7
pp. 506 – 510

Abstract

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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.

Published in Chinese Journal of Lung Cancer

ISSN: 1009-3419 (Print); 1999-6187 (Online)
Publisher: Chinese Anti-Cancer Association; Chinese Antituberculosis Association
Country of publisher: China
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: http://www.lungca.org

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Abstract

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