Direkt zum Inhalt

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

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

Barnett, Helen, Boix, Oliver, Kontos, Dimitris und Jaki, Thomas (2024) Joint TITE-CRM: A Design for Dose Finding Studies for Therapies with Late-Onset Safety and Activity Outcomes. Statistics in Biopharmaceutical Research 17 (1), S. 149-160.

Veröffentlichungsdatum dieses Volltextes: 22 Sep 2025 06:19
Artikel
DOI zum Zitieren dieses Dokuments: 10.5283/epub.77766


Zusammenfassung

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 ...

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.



Beteiligte Einrichtungen


Details

DokumentenartArtikel
Titel eines Journals oder einer ZeitschriftStatistics in Biopharmaceutical Research
Verlag:Taylor & Francis Online
Band:17
Nummer des Zeitschriftenheftes oder des Kapitels:1
Seitenbereich:S. 149-160
Datum20 März 2024
InstitutionenInformatik und Data Science > Fachbereich Maschinelles Lernen und Data Science > Chair for Computational Statistics (Prof. Dr. Thomas Jaki)
Identifikationsnummer
WertTyp
10.1080/19466315.2024.2333388DOI
Stichwörter / KeywordsDose-finding, Late-onset activity, Late-onset toxicities, Model-Based, Phase I trials
Dewey-Dezimal-Klassifikation000 Informatik, Informationswissenschaft, allgemeine Werke > 004 Informatik
StatusVeröffentlicht
BegutachtetJa, diese Version wurde begutachtet
An der Universität Regensburg entstandenZum Teil
URN der UB Regensburgurn:nbn:de:bvb:355-epub-777660
Dokumenten-ID77766

Bibliographische Daten exportieren

Nur für Besitzer und Autoren: Kontrollseite des Eintrags

nach oben