Mütze, Tobias

[["dc.bibliographiccitation.firstpage","3968"],["dc.bibliographiccitation.issue","27"],["dc.bibliographiccitation.journal","Statistics in Medicine"],["dc.bibliographiccitation.lastpage","3985"],["dc.bibliographiccitation.volume","39"],["dc.contributor.author","Mütze, Tobias"],["dc.contributor.author","Salem, Susanna"],["dc.contributor.author","Benda, Norbert"],["dc.contributor.author","Schmidli, Heinz"],["dc.contributor.author","Friede, Tim"],["dc.date.accessioned","2021-04-14T08:24:52Z"],["dc.date.available","2021-04-14T08:24:52Z"],["dc.date.issued","2020"],["dc.identifier.doi","10.1002/sim.8702"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/81449"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-399"],["dc.relation.eissn","1097-0258"],["dc.relation.issn","0277-6715"],["dc.title","Blinded continuous information monitoring of recurrent event endpoints with time trends in clinical trials"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","883"],["dc.bibliographiccitation.issue","6"],["dc.bibliographiccitation.journal","Statistics in Medicine"],["dc.bibliographiccitation.lastpage","898"],["dc.bibliographiccitation.volume","36"],["dc.contributor.author","Mütze, Tobias"],["dc.contributor.author","Konietschke, Frank"],["dc.contributor.author","Munk, Axel"],["dc.contributor.author","Friede, Tim"],["dc.date.accessioned","2017-09-07T11:53:20Z"],["dc.date.available","2017-09-07T11:53:20Z"],["dc.date.issued","2016"],["dc.description.abstract","The ‘gold standard’ design for three-arm trials refers to trials with an active control and a placebo control in addition to the experimental treatment group. This trial design is recommended when being ethically justifiable and it allows the simultaneous comparison of experimental treatment, active control, and placebo. Parametric testing methods have been studied plentifully over the past years. However, these methods often tend to be liberal or conservative when distributional assumptions are not met particularly with small sample sizes. In this article, we introduce a studentized permutation test for testing non-inferiority and superiority of the experimental treatment compared with the active control in three-arm trials in the ‘gold standard’ design. The performance of the studentized permutation test for finite sample sizes is assessed in a Monte Carlo simulation study under various parameter constellations. Emphasis is put on whether the studentized permutation test meets the target significance level. For comparison purposes, commonly used Wald-type tests, which do not make any distributional assumptions, are included in the simulation study. The simulation study shows that the presented studentized permutation test for assessing non-inferiority in three-arm trials in the ‘gold standard’ design outperforms its competitors, for instance the test based on a quasi-Poisson model, for count data. The methods discussed in this paper are implemented in the R package ThreeArmedTrials which is available on the comprehensive R archive network (CRAN)."],["dc.identifier.doi","10.1002/sim.7176"],["dc.identifier.gro","3145059"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/2753"],["dc.language.iso","en"],["dc.notes.intern","Crossref Import"],["dc.notes.status","final"],["dc.relation.issn","0277-6715"],["dc.title","A studentized permutation test for three-arm trials in the ‘gold standard’ design"],["dc.type","journal_article"],["dc.type.internalPublication","unknown"],["dc.type.peerReviewed","no"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","126"],["dc.bibliographiccitation.issue","2"],["dc.bibliographiccitation.journal","Pharmaceutical Statistics"],["dc.bibliographiccitation.lastpage","143"],["dc.bibliographiccitation.volume","17"],["dc.contributor.author","Mütze, Tobias"],["dc.contributor.author","Schmidli, Heinz"],["dc.contributor.author","Friede, Tim"],["dc.date.accessioned","2020-12-10T14:07:07Z"],["dc.date.available","2020-12-10T14:07:07Z"],["dc.date.issued","2017"],["dc.identifier.doi","10.1002/pst.v17.2"],["dc.identifier.issn","1539-1604"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/70129"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-354"],["dc.title","Sample size re-estimation incorporating prior information on a nuisance parameter"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","106154"],["dc.bibliographiccitation.journal","Contemporary Clinical Trials"],["dc.bibliographiccitation.volume","98"],["dc.contributor.author","Mütze, Tobias"],["dc.contributor.author","Friede, Tim"],["dc.date.accessioned","2021-04-14T08:32:06Z"],["dc.date.available","2021-04-14T08:32:06Z"],["dc.date.issued","2020"],["dc.identifier.doi","10.1016/j.cct.2020.106154"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/83807"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-399"],["dc.relation.issn","1551-7144"],["dc.title","Data monitoring committees for clinical trials evaluating treatments of COVID-19"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]

[["dc.bibliographiccitation.firstpage","505"],["dc.bibliographiccitation.issue","4"],["dc.bibliographiccitation.journal","Statistics in Medicine"],["dc.bibliographiccitation.lastpage","521"],["dc.bibliographiccitation.volume","35"],["dc.contributor.author","Muetze, Tobias"],["dc.contributor.author","Munk, Axel"],["dc.contributor.author","Friede, Tim"],["dc.date.accessioned","2017-09-07T11:54:38Z"],["dc.date.available","2017-09-07T11:54:38Z"],["dc.date.issued","2016"],["dc.description.abstract","A three-arm clinical trial design with an experimental treatment, an active control, and a placebo control, commonly referred to as the gold standard design, enables testing of non-inferiority or superiority of the experimental treatment compared with the active control. In this paper, we propose methods for designing and analyzing three-arm trials with negative binomially distributed endpoints. In particular, we develop a Wald-type test with a restricted maximum-likelihood variance estimator for testing non-inferiority or superiority. For this test, sample size and power formulas as well as optimal sample size allocations will be derived. The performance of the proposed test will be assessed in an extensive simulation study with regard to type I error rate, power, sample size, and sample size allocation. For the purpose of comparison, Wald-type statistics with a sample variance estimator and an unrestricted maximum-likelihood estimator are included in the simulation study. We found that the proposed Wald-type test with a restricted variance estimator performed well across the considered scenarios and is therefore recommended for application in clinical trials. The methods proposed are motivated and illustrated by a recent clinical trial in multiple sclerosis. The R package Three Armed Trials, which implements the methods discussed in this paper, is available on CRAN. Copyright (C) 2015 John Wiley & Sons, Ltd."],["dc.identifier.doi","10.1002/sim.6738"],["dc.identifier.gro","3141727"],["dc.identifier.isi","000368944800006"],["dc.identifier.pmid","26388314"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/402"],["dc.language.iso","en"],["dc.notes.intern","WoS Import 2017-03-10"],["dc.notes.status","final"],["dc.notes.submitter","PUB_WoS_Import"],["dc.relation.eissn","1097-0258"],["dc.relation.issn","0277-6715"],["dc.title","Design and analysis of three-arm trials with negative binomially distributed endpoints"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.subtype","original"],["dspace.entity.type","Publication"]]

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[["dc.bibliographiccitation.journal","Statistics in Medicine"],["dc.contributor.author","Brunner, Edgar"],["dc.contributor.author","Vandemeulebroecke, Marc"],["dc.contributor.author","Mütze, Tobias"],["dc.date.accessioned","2021-06-01T09:42:33Z"],["dc.date.available","2021-06-01T09:42:33Z"],["dc.date.issued","2021"],["dc.identifier.doi","10.1002/sim.8967"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/85284"],["dc.language.iso","en"],["dc.notes.intern","DOI-Import GROB-425"],["dc.relation.eissn","1097-0258"],["dc.relation.issn","0277-6715"],["dc.title","Win odds: An adaptation of the win ratio to include ties"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]