一种药物临床试验质量评估方法的介绍

An approach to the method of drug clinical trial quality assessment

药物临床试验是新药研发过程的重要环节,提高药物临床试验的质量管理,保证临床试验数据和结果的完整、准确、真实、可靠,并保护受试者的权益,是药物临床试验的核心准则。但是,目前我国在《药物临床试验质量管理规范》(good clinical practice,GCP)评估方面,尚无统一的评价指标体系,也没有针对我国GCP进行评价的方法。为此就本机构在新药临床试验过程中实施的一种药物临床质量评估方法作介绍,该方法主要从药物临床试验质量的几个关键要素入手全面评估药物临床试验的质量,分别从项目的真实性情况、书面记录情况、研究者内部质量控制情况、研究进度情况4个方面进行综合评估,拟定了《药物临床试验项目质量评估表》,旨在为各药物临床试验机构的建设和管理及药物临床试验的质量提高提供参考。

Drug clinical trial is an important part on the process of drug development. Improving the quality of management of drug clinical trials and ensuring the clinical trial data and results is complete,accurate,true and reliable,and protecting the rights of the subjects is a core principle in drug clinical trials. However,there is no uniform evaluation system and method to assess quality management in clinical trials currently. And there is little known on how to evaluate the quality management of clinical trials properly. A method of drug clinical trial quality assessment in our hospital was introduced,which could be beneficial to improve the quality of GCP in China. From several key elements of drug clinical trials,this method conducted comprehensive evaluation of the quality of drugclinical trials from4 aspects of authenticity,written records,internal quality control by researchers,research progress. The project quality evaluation table of drug clinical trials was developed to provide reference for the construction and management of drug clinical trials institutionsand the quality improvement of drug clinical trials.