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[Safety assessment in radomized controlled clinical trials]
Yuxiu Liu1, Chen Yao, Feng Chen
1Department of Medical Information, Nanjing General Hospital of Nanjing Command, PLA, Nanjing, Jiangsu 210002, China.
Zhonghua Nan Ke Xue = National Journal of Andrology
|February 26, 2004
Abstract
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.
Conclusion:
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.