[Safety assessment in radomized controlled clinical trials].
OBJECTIVE
To introduce some methods of safety assessment in randomized controlled clinical trials.


METHODS
Recent 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.


CONCLUSIONS
With 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.
Department of Medical Information, Nanjing General Hospital of Nanjing Command, PLA, Nanjing, Jiangsu 210002, China.
Yuxiu
Y
Liu
Chen
C
Yao
Feng
F
Chen
Gaokui
G
Zhang
Jielai
J
Xia
Qiquang
Q
Chen
Binghua
B
Su
D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000009:adverse effects* / Q000379:methods; D012449:Safety