A New Margin Function for Anti-infective Trials

  •  Félix -Arao    
  •  Hortensia Reyes-Cervantes    
  •  José Castro-Alva    


In diverse contexts comparison of groups is giving frequently. Particularly, comparison of groups based on non-inferiority statistical tests is becoming more frequent and have had a very special boom in clinical trials, especially in trials related to testing new anti-infective products. Non-inferiority tests are statistical procedures that allow verify whether a sample provides sufficient evidence that the efficacy of a new treatment is not substantially inferior to the known efficacy of a standard treatment. For the selection of the non-inferiority margin for anti-infective trials, the Food and Drug Administration (FDA) and the Committee for Proprietary of Medical Products (CPMP) have provided some general guidance. In this investigation we propose a new parametric family of margin functions for testing non-inferiority in the context of anti-infective trials. One important feature of this parametric family is that fit together recommendations of FDA and CPMP jointly with some other important mathematical properties underlined in this research.

This work is licensed under a Creative Commons Attribution 4.0 License.
  • ISSN(Print): 1927-7032
  • ISSN(Online): 1927-7040
  • Started: 2012
  • Frequency: bimonthly

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