Ethical Review on Placebo Control in Ophthalmic New Drug Clinical Trials / 中国医学伦理学
Chinese Medical Ethics
; (6): 189-190, 2014.
Article
in Chinese
| WPRIM (Western Pacific)
| ID: wpr-446398
Responsible library:
WPRO
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 .
Full text:
Available
Database:
WPRIM (Western Pacific)
Type of study:
Controlled clinical trial
/
Practice guideline
Aspects:
Ethical aspects
Language:
Chinese
Journal:
Chinese Medical Ethics
Year:
2014
Document type:
Article