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

Research output: Contribution to Journal/Magazine › Journal article › peer-review

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Joint TITE-CRM: A Design for Dose Finding Studies for Therapies with Late-Onset Safety and Activity Outcomes. / Barnett, Helen; Boix, Oliver; Kontos, Dimitris et al.
In: Statistics in Biopharmaceutical Research, Vol. 17, No. 1, 02.01.2025, p. 149-160.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

Harvard

Barnett, H, Boix, O, Kontos, D & Jaki, T 2025, 'Joint TITE-CRM: A Design for Dose Finding Studies for Therapies with Late-Onset Safety and Activity Outcomes', Statistics in Biopharmaceutical Research, vol. 17, no. 1, pp. 149-160. https://doi.org/10.1080/19466315.2024.2333388

APA

Barnett, H., Boix, O., Kontos, D., & Jaki, T. (2025). Joint TITE-CRM: A Design for Dose Finding Studies for Therapies with Late-Onset Safety and Activity Outcomes. Statistics in Biopharmaceutical Research, 17(1), 149-160. https://doi.org/10.1080/19466315.2024.2333388

Vancouver

Barnett H, Boix O, Kontos D, Jaki T. Joint TITE-CRM: A Design for Dose Finding Studies for Therapies with Late-Onset Safety and Activity Outcomes. Statistics in Biopharmaceutical Research. 2025 Jan 2;17(1):149-160. Epub 2024 Apr 17. doi: 10.1080/19466315.2024.2333388

Author

Barnett, Helen ; Boix, Oliver ; Kontos, Dimitris et al. / Joint TITE-CRM : A Design for Dose Finding Studies for Therapies with Late-Onset Safety and Activity Outcomes. In: Statistics in Biopharmaceutical Research. 2025 ; Vol. 17, No. 1. pp. 149-160.

Bibtex

@article{7c5519171c48478aa1019ccbe6e8f5f4,
title = "Joint TITE-CRM: A Design for Dose Finding Studies for Therapies with Late-Onset Safety and Activity Outcomes",
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 the follow up of multiple cycles. In this work we present and assess the Joint TITE-CRM, a model-based design for late onset toxicities and activity based on the well-known TITE-CRM. It is found to be superior to the currently available alternative designs that account for late onset bivariate outcomes, as well as being both intuitive and computationally feasible.",
keywords = "Dose-finding, Late-onset activity, Late-onset toxicities, Model-Based, Phase I trials",
author = "Helen Barnett and Oliver Boix and Dimitris Kontos and Thomas Jaki",
year = "2025",
month = jan,
day = "2",
doi = "10.1080/19466315.2024.2333388",
language = "English",
volume = "17",
pages = "149--160",
journal = "Statistics in Biopharmaceutical Research",
issn = "1946-6315",
publisher = "Taylor and Francis Ltd.",
number = "1",

}

RIS

TY - JOUR

T1 - Joint TITE-CRM

T2 - A Design for Dose Finding Studies for Therapies with Late-Onset Safety and Activity Outcomes

AU - Barnett, Helen

AU - Boix, Oliver

AU - Kontos, Dimitris

AU - Jaki, Thomas

PY - 2025/1/2

Y1 - 2025/1/2

N2 - 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 the follow up of multiple cycles. In this work we present and assess the Joint TITE-CRM, a model-based design for late onset toxicities and activity based on the well-known TITE-CRM. It is found to be superior to the currently available alternative designs that account for late onset bivariate outcomes, as well as being both intuitive and computationally feasible.

AB - 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 the follow up of multiple cycles. In this work we present and assess the Joint TITE-CRM, a model-based design for late onset toxicities and activity based on the well-known TITE-CRM. It is found to be superior to the currently available alternative designs that account for late onset bivariate outcomes, as well as being both intuitive and computationally feasible.

KW - Dose-finding

KW - Late-onset activity

KW - Late-onset toxicities

KW - Model-Based

KW - Phase I trials

U2 - 10.1080/19466315.2024.2333388

DO - 10.1080/19466315.2024.2333388

M3 - Journal article

C2 - 39877730

VL - 17

SP - 149

EP - 160

JO - Statistics in Biopharmaceutical Research

JF - Statistics in Biopharmaceutical Research

SN - 1946-6315

IS - 1

ER -