Joint time-to-event partial order continual reassessment method and Joint time-to-event Bayesian logistic regression model: Statistical designs for dual agent phase I/II dose finding studies with late-onset toxicity and activity outcomes

URN zum Zitieren dieses Dokuments:

urn:nbn:de:bvb:355-epub-787306 Copy

DOI zum Zitieren dieses Dokuments:

10.5283/epub.78730 Copy

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

Lizenz: Creative Commons Namensnennung 4.0 International PDF - Veröffentlichte Version (1MB)

Veröffentlichungsdatum dieses Volltextes: 24 Feb 2026 13:07

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Details

Dokumentenart:	Artikel
Open Access Art:	CC-Lizenz
Titel eines Journals oder einer Zeitschrift:	Statistical Methods in Medical Research
Verlag:	Sage
Band:	35
Nummer des Zeitschriftenheftes oder des Kapitels:	1
Seitenbereich:	S. 186-204
Datum:	5 Dezember 2025
Institutionen:	Informatik und Data Science > Fachbereich Maschinelles Lernen und Data Science > Chair for Computational Statistics (Prof. Dr. Thomas Jaki)
Sonstige Projekte:	UK Medical Research Council, MC_UU_00040/03
Identifikationsnummer:	Wert Typ 10.1177/09622802251403384 DOI
Stichwörter / Keywords:	dose-finding, late-onset toxicities, late-onset activity, dual agent, phase I trials, model-based
Dewey-Dezimal-Klassifikation:	000 Informatik, Informationswissenschaft, allgemeine Werke > 004 Informatik
Status:	Veröffentlicht
Begutachtet:	Ja, diese Version wurde begutachtet
An der Universität Regensburg entstanden:	Zum Teil
Dokumenten-ID:	78730

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Zusammenfassung

Dual agent dose-finding trials study the effect of a combination of more than one agent, where the objective is to find the Maximum Tolerated Dose Combination, the combination of doses of the two agents that is associated with a pre-specified risk of being unsafe. In a Phase I/II setting, the objective is to find a dose combination that is both safe and active, the Optimal Biological Dose, that ...

Zusammenfassung

Dual agent dose-finding trials study the effect of a combination of more than one agent, where the objective is to find the Maximum Tolerated Dose Combination, the combination of doses of the two agents that is associated with a pre-specified risk of being unsafe. In a Phase I/II setting, the objective is to find a dose combination that is both safe and active, the Optimal Biological Dose, that optimises a criterion based on both safety and activity. Since Oncology treatments are typically given over multiple cycles, both the safety and activity outcome can be considered as late-onset, potentially occurring in the later cycles of treatment. This work proposes two model-based designs for dual-agent dose finding studies with late-onset activity and late-onset toxicity outcomes, the Joint time-to-event (TITE) partial order continual reassessment method and the Joint TITE Bayesian logistic regression model. Their performance is compared alongside a model-assisted comparator in a comprehensive simulation study motivated by a real trial example, with an extension to consider alternative sized dosing grids. It is found that both model-based methods outperform the model-assisted design. Whilst on average the two model-based designs are comparable, this comparability is not consistent across scenarios.

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Metadaten zuletzt geändert: 24 Feb 2026 13:14

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