Review of Ethical Issues in the Preclinical and Clinical Trial of Drug
10.12026/j.issn.1001-8565.2017.04.23
- VernacularTitle:药物在临床前及临床试验研究中的伦理问题综述
- Author:
Shuibing LIU
;
Lei LIU
;
Dongguang WANG
- Keywords:
New Drug Research and Development;
Preclinical Drug Research;
Medical Animal Ethics Committee;
Clinical Trial of Drugs
- From:
Chinese Medical Ethics
2017;30(4):491-494
- CountryChina
- Language:Chinese
-
Abstract:
The ethical issues are different at different research stages of drug discovery.At the preclinical trial phase,laboratory animals are indispensable.The medical animal ethics committees need to approve and supervise animal testing during the experiment whether it adheres to the principles of animal protection,animal welfare principles and ethicalprinciples.At the phase of clinical trials,the subject of drug is human.The medical ethics committee should take full account of the ethical issues arising from the special medicine,special populations and disease in the process of trial and formulate detailed and feasible clauses,thus to ensure the scientificity of the trial and the rights and interests of subjects and promote new drug discovery and integrate with international standards.
