肿瘤专科医院药物临床试验质量规范管理体系研究

Study of Quality Standard Management System for Pharmaceutical Clinical Trials in Cancer Hospital

我国医院开展临床试验存在研究方案设计缺乏科学性,试验过程缺乏规范性,数据质量有待提高等问题。针对我国抗肿瘤药物临床试验现状,提出构建临床试验质量规范管理体系实践路径,包括在试验启动前多方参与共同修订研究方案确保其科学性;在试验过程中建立临床试验制度/SOP体系、质控体系、SAE报告管理体系;在试验后期建立数据质量管理体系、结果评估体系等。

There are still some problems in clinical trials in Chinese hospitals,such as the lack of scientific design,the lack of standardization,and the need to improve the quality of data,etc.In view of the current situation of anti-tumor pharmaceutical clinical trials in China,the practical path of clinical trial quality standard management system was put forward,including multi-party participation in the revision of the research program before the start of the trial to ensure its scientific nature;establishment of clinical trial system/SOP system,quality control system and SAE report management system during the clinical trials;establishment of data quality management system and result evaluation system in the later stage of the clinical trials.