title: General issues and precautions in the design for clinical trials of investigational new drugs.
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.
authors.affiliation: Consulting Center of Biomedical Statistics, Academy of Military Medical Sciences, Beijing 100850, China. lphu812@sina.com
authors.forename: Liang-ping
authors.initials: LP
authors.lastname: Hu
authors.forename: Xiao-lei
authors.initials: XL
authors.lastname: Bao
mesh_terms: D002986:Clinical Trials as Topic; D015507:Drugs, Investigational / Q000627:therapeutic use*; D006801:Humans; D012107:Research Design
chemical_list: D015507:Drugs, Investigational