新药临床试验设计中普遍存在的问题及防范措施

doi:10.3736/jcim20110204

Abstract

The general problems existing in the clinical trials of investigational new drugs involve some key aspects such as the guiding principles, research designs, quality controls and statistical analyses. This paper explores the eight general issues in the clinical trials of investigational new drugs and presents precautionary measures with high operability. Research on the clinical trials of investigational new drugs is a complex project, which should be carried out strictly according to the policies, laws, criteria and operating rules set by related agencies. The neglect of research designs and data analyses will lead clinical trials to failure.

Key words: statistics, medical, drugs, investigational, clinical trial, research design

Liang-ping Hu, Xiao-lei Bao. General issues and precautions in the design for clinical trials of investigational new drugs. Journal of Chinese Integrative Medicine, 2011, 9(2): 138-142.

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URL: http://www.jcimjournal.com/EN/10.3736/jcim20110204

http://www.jcimjournal.com/EN/Y2011/V9/I2/138

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References 2

[1]	Hu LP, Liu HG . The discrimination and interpretation of errors of experimental designs in the medical papers[J]. J Chin Integr Med, 2007,5(6):707-711
	胡良平, 刘惠刚 . 医学论文中实验设计方面的错误辨析与释疑[J]. 中西医结合学报, 2007,5(6):707-711
[2]	Hu LP, Liu HG . An application of mind on statistics and the triple-type theory in the scientific research work of biomedicine[J]. J Chin Integr Med, 2007,5(2):216-219
	胡良平, 刘惠刚 . 统计学思想与三型理论在生物医学科研中的应用[J]. 中西医结合学报, 2007,5(2):216-219

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General issues and precautions in the design for clinical trials of investigational new drugs

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