中国医学伦理学2016，Vol.29Issue(2)：308-310,3.
肿瘤科药物临床试验实施中常见的伦理问题分析与对策探讨
Analysis and Countermeasures of Common Ethical Issues in the Medical Clinical Trial Implementation in Oncology Department
李爱敏 1田丽 1张红 2张莹 1张明智 1苗金红3
作者信息
- 1. 郑州大学第一附属医院肿瘤科，河南 郑州 450052
- 2. 郑州大学第一附属医院机构办公室，河南 郑州 450052
- 3. 郑州大学第一附属医院综合医学部，河南 郑州 450052
- 折叠
摘要
Abstract
This paper reviewed the common ethical issues in oncology drug clinical trials implementation of one hospital, such as the auditing and implementation of research protocols were not strict, the quality of research-ers needed to be improved, the hardware facilities for drug clinical trial was lacking, the informed consent signature was not standard, and the professional quality control was lacking. After corresponding countermeasures had been taken, such as the strict examination of research programs, strengthening the research team construction, taking the focus of GCP and SOP training, equipping hardware facilities for drug clinical trials, standardizing of ICF signa-ture, and the joint implementation of the quality control in hospital and departments, the researchers′ professional quality was further improved, which established a good foundation for better implementation of the drugs clinical tri-als and protection of the participants′interests.关键词
肿瘤科/药物临床试验/受试者/伦理问题Key words
Oncology Department/Drug Clinical Trial/Subjects/Ethical Issues分类
医药卫生引用本文复制引用
李爱敏,田丽,张红,张莹,张明智,苗金红..肿瘤科药物临床试验实施中常见的伦理问题分析与对策探讨[J].中国医学伦理学,2016,29(2):308-310,3.
