药物临床试验外包风险及管理策略分析  

Analysis of outsourcing risks and management strategies of drug clinical trials

作　　者：张凯平 梁燕玲 陈炜璇 彭丽华 成金乐 ZHANG Kaiping;LIANG Yanling;CHEN Weixuan;PENG Lihua;CHENG Jinle(Key Laboratory of Technologies and Applications of Ultrafine Granular Powder of Chinese Materia Medica State Administration of Traditional Chinese Medicine,Zhongshan 528437,China;Zhongshan Zhongzhi Pharmaceutical Group Co.Ltd.,Zhongshan 528437,China)

机构地区：[1]国家中医药管理局中药破壁饮片技术与应用重点研究室,广东中山528437 [2]中山市中智药业集团有限公司,广东中山528437

出　　处：《药物评价研究》2022年第1期171-176,共6页Drug Evaluation Research

基　　金：国家地方联合工程研究中心项目(发改办高技[2019]180号);广东省中药破壁饮片工程实验室项目(粤发改创新函[2018]3149号);中山市重大科技专项(科技强企计划)项目(2018010308)。

摘　　要：药物临床试验作为新药研发的关键环节,其实施质量至关重要。目前,多数药品研发企业采用与合同研究组织(CRO)合作的方式,将临床试验项目外包。而在实际合作过程中,CRO在组织架构、人员配备及管理、专业水平、项目质量控制、与申办方沟通等方面可能存在一定问题,从而导致临床试验项目存在缺陷或失败。为了降低研发风险,药品研发企业应选择合适的CRO,同时建立质量控制体系,对临床试验项目的实施质量及进展进行有效管理,确保临床试验数据的真实性、完整性和准确性。对药物临床试验项目外包的风险及管理策略进行了阐述与分析,为药物临床试验外包的管理提供参考。Drug clinical trials are a key link in drug development,and its quality is very important.In order to make effective use of resources,most drug R&D enterprises cooperate with CRO to outsource clinical trials.However,In the process of cooperation,CRO may have some problems in organizational structure,personnel management,professionalism,project quality control,communication and other aspects,which may lead to the failure of clinical trial projects.In order to reduce the risk,drug R&D companies should select the appropriate CRO and establish a quality control system,Manage projects well to ensure the authenticity,completeness and accuracy of clinical trial data.This paper analyzes the risk and management of drug clinical trial outsourcing.

关 键 词：药物临床试验 新药研发 合同研究组织 临床试验数据 

分 类 号：R969.4[医药卫生—药理学]