Constructing Convenient Boundary Functions for Anti-Infective Trials

Almendra-Arao, Félix; Reyes-Cervantes, Hortensia; Castro-Alva, José Juan

doi:10.17654/bo013020135

Cited by 1 publication

(4 citation statements)

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“…As seen in Almendra-Arao et al (Almendra-Arao et al, 2016), difference between proportions, the FDA step function as well as the proportions ratio are not very useful dissimilarity measures from the point of view under consideration in this work. For that reason, we will not compare the new proposal with those.…”

Section: Comparison Of the New Proposal With Some Useful Non-inferiormentioning

confidence: 80%

“…Almendra-Arao et al (Almendra-Arao et al, 2016) have also noted that the other dissimilarity measures that behave well are the Röhmel's proposals. In this section we compare the family of boundary functions proposed in this work with Röhmel's proposals, doing these comparisons in the same way as in previous section, that is, by setting the difference between the areas of the corresponding margin functions equal to zero.…”

Section: Difference Between Areas To Röhmel's Proposalsmentioning

confidence: 89%

“…As mentioned above, Almendra-Arao et al (Almendra-Arao et al, 2016) have established properties that they considered as desirable to fulfill any margin function for anti-infective non-inferiority trials in order to satisfy requirements of the FDA and the CPMP guides for non-inferiority trials of anti-infective drugs besides fulfilling some other convenient features. These properties are stated in the following definition.…”

Section: Proposing a New Margin Functionmentioning

confidence: 99%

“…In a recent article Almendra-Arao, Reyes-Cervantes and Castro-Alva (Almendra- Arao et al, 2016) examined the suggestions of the FDA and CPMP in addition to several known margin functions for non-inferiority in the case of anti-infective trials. These authors established useful properties that should fulfill the non-inferiority margin functions for anti-infective trials in such a way that they comply with the suggestions of the FDA and CPMP as well as possessing suitable mathematical properties and they called these functions FCAT functions.…”

Section: Introductionmentioning

confidence: 99%

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A New Margin Function for Anti-infective Trials

Almendra-Arao¹,

Reyes-Cervantes²,

Castro-Alva³

2017

IJSP

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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.

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Section: Comparison Of the New Proposal With Some Useful Non-inferiormentioning

confidence: 80%

Section: Difference Between Areas To Röhmel's Proposalsmentioning

confidence: 89%

Section: Proposing a New Margin Functionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations