基于文献分析我国临床试验药物管理风险  

Analyzing the Risk of Clinical Trial Drug Management in China Based on Literature

作　　者：自雪梅 尹健彬 杨美芬 赵正科 陈沫 ZI Xue-mei;YIN Jian-bin;YANG Mei-fen;ZHAO Zheng-ke;CHEN Mo(Chuxiong Yi Autonomous Prefecture People's Hospital Drug Clinical Trial Institution,Chuxiong 650000,China)

机构地区：[1]楚雄彝族自治州人民医院药物临床试验机构,云南楚雄650000

出　　处：《海峡药学》2025年第2期115-118,共4页Strait Pharmaceutical Journal

摘　　要：目的梳理临床试验中药物管理的风险因素,提高药物风险管理水平。方法采用文献分析法梳理中国药物临床试验药物风险管理相关文献,采用文本分析法总结和提炼临床试验药物管理的风险。结果临床试验药物管理风险类别分为6大类,即文件或记录缺失、温湿度管理、信息不一致、不规范操作、人员管理、与申办者相关,具体风险点74项。结论在临床试验用药物的管理中,可结合风险因素,不断完善管理制度和章程,提前制定风险管理计划,加强与申办者的沟通,更好地开展药物临床试验。OBJECTIVE To comprehensively assess the risk factors influencing drug management in clinical trials and elevate the standard of drug risk management practices.METHODS A meticulous literature review was undertaken,focusing on Chinese publications pertaining to drug risk management in clinical trials.Employing text analysis techniques,we systematically summarized and distilled the key risks associated with the administration of drugs within these trials.RESULTS The identified risks in clinical trial drug management were categorized into six distinct domains:deficiencies in documentation or record-keeping,inadequate temperature and humidity control,discrepancies in information,non-compliance with standard operating procedures,personnel management issues,and sponsor-related risks.These domains encompassed a total of 74 specific risk points,highlighting the multifaceted nature of potential challenges.CONCLUSION To optimize drug management in clinical trials,it is imperative to integrate a holistic approach that encompasses all identified risk factors.This necessitates continuous refinement of management systems and regulations,the formulation of proactive risk mitigation strategies,enhanced communication with sponsors,and the efficient execution of drug clinical trials,thereby ensuring the safety,efficacy,and integrity of the trial process.

关 键 词：药物临床试验 药物管理 试验用药风险 

分 类 号：R95[医药卫生—药学]