[1]曹蔚玮翟慧文李济宾潘旭芝张妮洁彭望清.肿瘤专科医院药物临床试验质量规范管理体系研究[J].中国卫生质量管理,2020,27(01):036-38.[doi:10.13912/j.cnki.chqm.2020.27.1.09]

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肿瘤专科医院药物临床试验质量规范管理体系研究

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《中国卫生质量管理》[ISSN:1006-7515/CN:CN 61-1283/R]

Keywords:: Cancer Hospital; Pharmaceutical; Clinical Trials; Quality Standard Management System

摘要:: 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。

Abstract:: 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.

［1］国家食品药品监督管理总局，国家卫生和计划生育委员会.关于药物临床试验机构开展人体生物等效性试验的公告［EB/OL］.（2017-10-13）.http://www.nmpa.gov.cn/WS04/CL2093/229299.html.

[1]莫陶欣王丹杨煦冷家骅刘晶薛冬.基于DRGs肿瘤专科医院精细化管理探讨[J].中国卫生质量管理,2018,25(02):016.[doi:10.13912/j.cnki.chqm.2018.25.2.05]
[2]敬小梅李扬张兆晖郭鹏程川东.肿瘤专科医院如何开展多学科诊疗[J].中国卫生质量管理,2020,27(02):007.[doi:10.13912/j.cnki.chqm.2020.27.2.03]

更新日期/Last Update: 2020-01-28