Key Points for Quality Management in Phase Ⅰ Clinical Trials of Anti-Tumor Drugs
10.3971/j.issn.1000-8578.2025.24.1178
- VernacularTitle:抗肿瘤药物Ⅰ期临床试验质量管理要点
- Author:
Li GONG
1
;
Bin LIAO
1
;
Jie SHEN
1
;
Juan ZHAO
1
;
Yi GONG
1
;
Xiaoxiao LU
1
;
Huiyao YANG
1
;
Sha LI
1
;
Yongsheng LI
1
Author Information
1. Department of Phase Ⅰ Clinical Trial Ward, Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized Treatment, Chongqing University Cancer Hospital, Chongqing 400030, China.
- Publication Type:SPECIALFEATURE
- Keywords:
Anti-cancer drugs;
Phase Ⅰ clinical trial;
Quality control;
Full-process management
- From:
Cancer Research on Prevention and Treatment
2025;52(5):347-354
- CountryChina
- Language:Chinese
-
Abstract:
Phase Ⅰ clinical trials play a crucial role in the research and development of new drugs, serving as the initial studies to assess their safety, tolerability, effectiveness, and pharmacokinetic properties in humans. These trials involve uncertainties regarding safety and efficacy. Comprehensive management of all aspects of phase Ⅰ clinical trials for anti-tumor drugs is crucial to protect the rights and safety of participants. This article provides an in-depth analysis of the key points and precautions necessary for effective quality control throughout the process. The analysis is informed by guidelines such as the “Good Clinical Practice for Drugs” “Key Points and Judgment Principles for Drug Registration Verification” “Key Points and Judgment Principles for Supervision and Inspection of Drug Clinical Trial Institutions” and the standard operating procedures for quality control of the center. Topics discussed include informed consent, inclusion criteria, experimental drugs, biological samples, adverse events, and serious adverse events. The goal is to standardize quality control in phase Ⅰ clinical trials of anti-tumor drugs, ensure the authenticity and reliability of clinical trial data, and protect the rights and safety of participants.
