Safety assessment in radomized controlled clinical trials.
- Author:
Yuxiu LIU
1
;
Chen YAO
;
Feng CHEN
;
Gaokui ZHANG
;
Jielai XIA
;
Qiquang CHEN
;
Binghua SU
Author Information
- Publication Type:Journal Article
- MeSH: Humans; Randomized Controlled Trials as Topic; adverse effects; methods; Safety
- From: National Journal of Andrology 2004;10(1):74-79
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo introduce some methods of safety assessment in randomized controlled clinical trials.
METHODSRecent advances and current parctice in normalized safety assessment were reviewed and relevant data analyzed. RESTULTS: The statistical issues including analysis and presentation of adverse events data and laboratory data were involved and summed up.
CONCLUSIONWith the progressive development of randomized controlled clinical trials in China, the methods introduced in this paper are sure to prove of consultative value for the safety assessment.
