药物临床试验用药品全流程管理分析探讨

目的：研究国内外关于试验用药品的相关法规和文献，分析相关问题和解决办法。方法：从中国知网、万方、维普等数据库，检索临床试验用药品相关文献，按照试验流程，分析试验各方如申办者/合同研究组织、研究者、药物临床试验机构、伦理审查委员会等职责和问题。结果：药物临床试验质量体系建设是临床试验质量保证的重要内容，从试验用药品生产、运输、使用、药物安全性等环节进行阐述，现已得到较全面的研究成果。结论：通过分析研究临床试验用药品管理流程中的政策和法规，提出相关问题和解决办法，有利于提高试验用药品管理质量，保护受试者权益和安全，保证试验顺利开展，并有重要的借鉴学习作用。

Analysis and Research on the Whole Process Management of ExperimentalDrugs for Clinical Trials

Objective: To study the relevant laws and regulations and literature on experimental drugs at homeand abroad, and analyze the relevant problems and solutions. Methods: Literatures related to drugs used inclinical trials were retrieved from databases such as CNKI, Wanfang, VIP, etc. According to the trial process, theresponsibilities and issues of trial parties such as the sponsors/contract research organization (CRO), researchers,drug clinical trial institutions, and ethical review committees were analyzed. Results: The construction of a qualitysystem for drug clinical trials was an important part of quality assurance in clinical trials. There articles elaboratedon the production, transportation, use, and safety of experimental drugs, and obtained more comprehensiveresearch results. Conclusion: This article analyzes the policies and regulations in the management process ofclinical experimental drugs, and propose the relevant problems and solutions, which is benefi cial for improvingthe quality of experimental drug management, protecting the rights and safety of subjects, and ensuring the smoothprogress of trials, and has an important reference and learning signifi cance.