Ethical Review on Placebo Control in Ophthalmic New Drug Clinical Trials
- VernacularTitle:眼科新药临床试验中安慰剂对照的伦理审查问题探讨
- Author:
Yifeng JIANG
;
Lei MA
;
Shuya ZHANG
;
Erjun GONG
;
Yanhong ZHU
- Publication Type:Journal Article
- Keywords:
Ethics Innovation;
Placebo;
Ophthalmology;
New Drug;
Clinical Trial;
Ethical Review
- From:
Chinese Medical Ethics
2014;(2):189-190
- CountryChina
- Language:Chinese
-
Abstract:
In China , some ophthalmic new drug clinical trials used placebo as control .Two principles should be con-sidered in ethical review when placebo was used in these ophthalmic new drug clinical trials .Firstly, using placebo couldn't lead to irreversible or permanent vision loss .Secondly , there should be proper risk management in protocol and risk dis-closure in consent process .There are several important factors , including effects of standard treatment , risks of using pla-cebo, risk management in protocol and risk information in informed consent form , which should be used to assess the ra-tionality of placebo in ethical review .
