A case study in non-inferiority margin selection in a two-arm trial

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dc.contributor.author Liang, Xiao
dc.date.accessioned 2017-07-31T21:25:28Z
dc.date.available 2017-07-31T21:25:28Z
dc.date.issued 2017-08-01
dc.identifier.uri http://hdl.handle.net/2097/36191
dc.description.abstract Non-inferiority trials have been widely used in many medical areas. The goal of a non-inferiority trial is to show that a new test therapy is either better or not too much worse than the active control rather than showing the test therapy is superior to a negative control (i.e. placebo). The appeal of a non-inferiority trial is that it is often unethical to give some patients a treatment with no therapeutic benefit. When designing a non-inferiority trial, the issues of assay sensitivity, sample size, constancy condition, and a suitable non-inferiority margin need to be considered. A poor choice of the non-inferiority margin is a major reason that many non-inferiority trials fail. A numerical example is presented to show how to estimate the non-inferiority margin without historical data. en_US
dc.language.iso en_US en_US
dc.publisher Kansas State University en
dc.subject non-inferiority trial en_US
dc.subject non-inferiority margin en_US
dc.subject superiority margin en_US
dc.title A case study in non-inferiority margin selection in a two-arm trial en_US
dc.type Report en_US
dc.description.degree Master of Science en_US
dc.description.level Masters en_US
dc.description.department Department of Statistics en_US
dc.description.advisor Christopher Vahl en_US
dc.date.published 2017 en_US
dc.date.graduationmonth August en_US

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