肿瘤防治研究2025，Vol.52Issue(5)：347-354,8.DOI:10.3971/j.issn.1000-8578.2025.24.1178
抗肿瘤药物Ⅰ期临床试验质量管理要点
Key Points for Quality Management in Phase Ⅰ Clinical Trials of Anti-Tumor Drugs
摘要
Abstract
PhaseⅠclinical 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 Ⅰclinical 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 phaseⅠclinical trials of anti-tumor drugs,ensure the authenticity and reliability of clinical trial data,and protect the rights and safety of participants.关键词
抗肿瘤药物/Ⅰ期临床试验/质量控制/全流程管理Key words
Anti-cancer drugs/PhaseⅠclinical trial/Quality control/Full-proc-ess management分类
药学引用本文复制引用
龚莉,廖斌,沈杰,赵娟,龚奕,卢潇潇,杨辉尧,李沙,李咏生..抗肿瘤药物Ⅰ期临床试验质量管理要点[J].肿瘤防治研究,2025,52(5):347-354,8.基金项目
重庆市中青年医学卓越团队 （）
国家杰出青年后备人才培养计划 （）
重庆大学附属肿瘤医院科研能力提升项目(Y2024003) （Y2024003）
重庆市沙坪坝区技术创新项目(2024143) Funding for Chongqing Young and Middle-Aged Medical Excellence Team （2024143）
National Outstanding Youth Res-erve Talent Training Project （）
Research Capacity Enhancement Project of Cho-ngqing University Cancer Hospital(No.Y2024003) （No.Y2024003）
Technological Innovation Project of Chongqing Shapingba Dis-trict(No.2024143) （No.2024143）
