Analysis and Countermeasures of Common Ethical Issues in the Medical Clinical Trial Implementation in Oncology Department
- VernacularTitle: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
- Author:
Aimin LI
;
Li TIAN
;
Hong ZHANG
;
Ying ZHANG
;
Mingzhi ZAHNG
;
Jinhong MIAO
- Publication Type:Journal Article
- Keywords:
Oncology Department;
Drug Clinical Trial;
Subjects;
Ethical Issues
- From:
Chinese Medical Ethics
2016;29(2):308-310
- CountryChina
- Language:Chinese
-
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.
