Adaptive designs for drug combination informed by longitudinal model for the response

Tobias Mielke () and Vladimir Dragalin
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Tobias Mielke: Janssen
Vladimir Dragalin: Janssen

Statistical Papers, 2019, vol. 60, issue 2, No 2, 355-371

Abstract: Abstract Objectives in Phase II drug combination studies are to estimate the efficacy response surface for the combination of doses of different drugs and to select the most efficient combination for the final Phase III clinical trial. One problem is to find an optimal design that allocates subjects to the dose-combinations which will maximize the information obtained in the trial. Adaptive designs help in these situations to ensure high efficiency of the study design. We are using a binary efficacy endpoint and consider the practical situation when the timing of the endpoint assessment period on the subject level is considerably longer relative to the inter-arrival time of subjects. This poses implementation challenges for the adaptive design. A solution to the adaptive design problem by using time-to-event models as longitudinal model will be presented.

Keywords: Adaptive design; Dose combination study; Delayed response (search for similar items in EconPapers)
Date: 2019
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DOI: 10.1007/s00362-018-01073-9

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