Joint TITE-CRM: A Design for Dose Finding Studies for Therapies with Late-Onset Safety and Activity Outcomes

URN to cite this document:: urn:nbn:de:bvb:355-epub-777660
DOI to cite this document:: 10.5283/epub.77766

Barnett, Helen ; Boix, Oliver ; Kontos, Dimitris ; Jaki, Thomas

License: Creative Commons Attribution 4.0
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Date of publication of this fulltext: 22 Sep 2025 06:19

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Abstract

In Phase I/II dose-finding trials, the objective is to find the Optimal Biological Dose (OBD), a dose that is both safe and shows sufficient activity that maximizes some optimality criterion based on safety and activity. In cancer, treatment is typically given over several cycles, complicating the identification of the OBD as both toxicity and activity outcomes may occur at any point throughout ...