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.
Artigo
em Chinês
| WPRIM (Pacífico Ocidental)
| ID: wpr-446398
Biblioteca responsável:
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 .
Texto completo:
Disponível
Base de dados:
WPRIM (Pacífico Ocidental)
Tipo de estudo:
Ensaio clínico controlado
/
Guia de prática clínica
Aspecto:
Aspectos éticos
Idioma:
Chinês
Revista:
Chinese Medical Ethics
Ano de publicação:
2014
Tipo de documento:
Artigo