Equivalence tests for binary efficacy-toxicity responses

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dc.contributor.authorMöllenhoff, Kathrin
dc.contributor.authorDette, Holger
dc.contributor.authorBretz, Frank
dc.date.accessioned2019-11-13T13:37:14Z
dc.date.available2019-11-13T13:37:14Z
dc.date.issued2019
dc.description.abstractClinical trials often aim to compare a new drug with a reference treatment in terms of efficacy and/or toxicity depending on covariates such as, for example, the dose level of the drug. Equivalence of these treatments can be claimed if the difference in average outcome is below a certain threshold over the covariate range. In this paper we assume that the efficacy and toxicity of the treatments are measured as binary outcome variables and we address two problems. First, we develop a new test procedure for the assessment of equivalence of two treatments over the entire covariate range for a single binary endpoint. Our approach is based on a parametric bootstrap, which generates data under the constraint that the distance between the curves is equal to the pre-specified equivalence threshold. Second, we address equivalence for bivariate binary (correlated) outcomes by extending the previous approach for a univariate response. For this purpose we use a 2-dimensional Gumbel model for binary efficacy-toxicity responses. We investigate the operating characteristics of the proposed approaches by means of a simulation study and present a case study as an illustration.en
dc.identifier.urihttp://hdl.handle.net/2003/38379
dc.identifier.urihttp://dx.doi.org/10.17877/DE290R-20312
dc.language.isoende
dc.relation.ispartofseriesDiscussion Paper / SFB823;26/2019
dc.subjectbinary dataen
dc.subjectbootstrapen
dc.subjectGumbel modelen
dc.subjectlogistic regressionen
dc.subjectdose responseen
dc.subject.ddc310
dc.subject.ddc330
dc.subject.ddc620
dc.subject.rswkDosis-Wirkungs-Analysede
dc.subject.rswkLogit-Modellde
dc.titleEquivalence tests for binary efficacy-toxicity responsesen
dc.typeTextde
dc.type.publicationtypeworkingPaperde
dcterms.accessRightsopen access
eldorado.secondarypublicationfalsede

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Sonderforschungsbereich (SFB) 823