《国家食品药品监督管理总局关于发布药物临床试验数据现场核查要点的公告》解读  

Interpretation of “Bulletin on the Key Points of On-site Drug Clinical Trial Date Inspection Released by China Food and Drug Administration”

作　　者：彭朋[1] 元唯安[1] 胡薏慧[1] 汤洁[1] 朱蕾蕾[1] 蒋健[1] 

机构地区：[1]上海中医药大学附属曙光医院国家药物临床试验机构,上海201203

出　　处：《中国新药杂志》2016年第7期771-774,共4页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2012ZX09303009-001);上海市中医药事业发展三年行动计划项目(ZY3-CCCX-2-1003)

摘　　要：目的:解读药物临床试验数据现场核查要点,以规范药物临床试验过程。方法:从通用内容、人体生物等效性/人体药动学试验数据现场核查要点、Ⅱ、Ⅲ期临床试验数据和疫苗临床试验数据现场核查要点3个方面解读核查要点,分析现场检查的注意事项。结果:目前,我国各期药物临床试验的质量距离比较严格的核查要点还有一定的差距,申办者、合同研究组织、研究者、药物临床试验机构都应该进一步学习相关法规,提高临床试验质量,确保上市后的药品安全。结论:以药物临床试验数据现场核查要点为标准,并严格执行该标准将是保证试验数据真实、完整、规范的重要途径。Objective： To interpret the key points of on-site drug clinical trial inspection in order to standardize the process of drug clinical trials. Methods： The key points of on-site drug clinical trial inspection were illustrated from three aspects including general contents,highlights of clinical trials on bioequivalence and pharmacokinetics,and main markings on phase Ⅱ / Ⅲ trials and vaccine trials. Then,the notes of inspection were analyzed.Results： At present,there is certain disparity between the levels of clinical trials at different phases in China and the strict requirements in the bulletin released by the CFDA,so the sponsors,contract research organizations,investigators,and drug clinical trial institutions should be further trained in regard of related regulations so as to improve the quality of clinical trials and ensure drug safety after they enter the market. Conclusion： Strict implement of the key points of on-site drug clinical trial inspection is an important approach to guarantee the validity,integrity and standardization of the clinical trial data.

关 键 词：药物临床试验 核查要点 解读 

分 类 号：R95[医药卫生—药学]