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

Consulting Center of Biomedical Statistics, Academy of Military Medical Sciences, Beijing 100850, China. lphu812@sina.com

Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine 2011 Feb

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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.

Citation

Liang-ping Hu, Xiao-lei Bao. General issues and precautions in the design for clinical trials of investigational new drugs. Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine. 2011 Feb;9(2):138-42