A case study in non-inferiority margin selection in a two-arm trial
dc.contributor.author | Liang, Xiao | |
dc.date.accessioned | 2017-07-31T21:25:28Z | |
dc.date.available | 2017-07-31T21:25:28Z | |
dc.date.graduationmonth | August | en_US |
dc.date.issued | 2017-08-01 | |
dc.date.published | 2017 | en_US |
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.description.advisor | Christopher I. Vahl | en_US |
dc.description.degree | Master of Science | en_US |
dc.description.department | Department of Statistics | en_US |
dc.description.level | Masters | en_US |
dc.identifier.uri | http://hdl.handle.net/2097/36191 | |
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 |