Key Points for Quality Management in Phase Ⅰ Clinical Trials of Anti-Tumor Drugs

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 mana...

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Published inZhongliu fangzhi yanjiu Vol. 52; no. 5; pp. 347 - 354
Main Authors Gong, Li, Liao, Bin, Shen, Jie, Zhao, Juan, Gong, Yi, Lu, Xiaoxiao, Yang, Huiyao, Li, Sha, Li, Yongsheng
Format Journal Article
LanguageChinese
English
Published Tianjin China Anti-Cancer Association 2025
Magazine House of Cancer Research on Prevention and Treatment
Subjects
Adverse events
anti-cancer drugs
Biological properties
Biological samples
Clinical trials
Drug development
Drugs
Effectiveness
full-process management
Informed consent
Pharmacokinetics
phase ⅰ clinical trial
Quality control
Quality management
R&D
Research & development
Safety
Safety management
Tumors
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Summary: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.
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ISSN:1000-8578
DOI:10.3971/j.issn.1000-8578.2025.24.1178