Optimal designs for dose finding studies with an active control

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dc.contributor.authorBenda, Norbert
dc.contributor.authorBretz, Frank
dc.contributor.authorDette, Holger
dc.contributor.authorKiss, Christine
dc.date.accessioned2011-09-28T06:32:05Z
dc.date.available2011-09-28T06:32:05Z
dc.date.issued2011-09-28
dc.description.abstractDose finding studies often compare several doses of a new compound with a marketed standard treatment as an active control. In the past, however, research has focused mostly on experimental designs for placebo-controlled dose finding studies. To the best of our knowledge, optimal designs for dose finding studies with an active control have not been considered so far. As the statistical analysis for an active controlled dose finding study can be formulated in terms of a mixture of two regression models, the related design problem is different to what has been investigated before in the literature. We present a rigorous approach to the problem of determining optimal designs for estimating the smallest dose achieving the same treatment effect as the active control. We determine explicitly the locally optimal designs for a broad class of models employed in such studies. We also discuss robust design strategies and determine related Bayesian and standardized minimax optimal designs. We illustrate the results by investigating alternative designs for a clinical trial which has recently appeared in a consulting project of one of the authors.en
dc.identifier.urihttp://hdl.handle.net/2003/29120
dc.identifier.urihttp://dx.doi.org/10.17877/DE290R-14272
dc.language.isoende
dc.relation.ispartofseriesDiscussion Paper / SFB 823;37/2011
dc.subjectminimax designen
dc.subjectactive controlen
dc.subjectdose estimationen
dc.subjectdose responseen
dc.subjectBayesian optimal designsen
dc.subject.ddc310
dc.subject.ddc330
dc.subject.ddc620
dc.titleOptimal designs for dose finding studies with an active controlen
dc.typeTextde
dc.type.publicationtypeworkingPaperde
dcterms.accessRightsopen access

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