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Mozgunov, Pavel ; Cro, Suzie ; Lingford‐Hughes, Anne ; Paterson, Louise M. ; Jaki, Thomas

A dose‐finding design for dual‐agent trials with patient‐specific doses for one agent with application to an opiate detoxification trial

Mozgunov, Pavel, Cro, Suzie, Lingford‐Hughes, Anne, Paterson, Louise M. und Jaki, Thomas (2021) A dose‐finding design for dual‐agent trials with patient‐specific doses for one agent with application to an opiate detoxification trial. Pharmaceutical Statistics 21 (2), S. 476-495.

Veröffentlichungsdatum dieses Volltextes: 30 Sep 2025 05:55
Artikel
DOI zum Zitieren dieses Dokuments: 10.5283/epub.77858


Zusammenfassung

There is a growing interest in early phase dose-finding clinical trials studying combinations of several treatments. While the majority of dose finding designs for such setting were proposed for oncology trials, the corresponding designs are also essential in other therapeutic areas. Furthermore, there is increased recognition of recommending the patient-specific doses/combinations, rather than a ...

There is a growing interest in early phase dose-finding clinical trials studying combinations of several treatments. While the majority of dose finding designs for such setting were proposed for oncology trials, the corresponding designs are also essential in other therapeutic areas. Furthermore, there is increased recognition of recommending the patient-specific doses/combinations, rather than a single target one that would be recommended to all patients in later phases regardless of their characteristics. In this paper, we propose a dose-finding design for a dual-agent combination trial motivated by an opiate detoxification trial. The distinguishing feature of the trial is that the (continuous) dose of one compound is defined externally by the clinicians and is individual for every patient. The objective of the trial is to define the dosing function that for each patient would recommend the optimal dosage of the second compound. Via a simulation study, we have found that the proposed design results in high accuracy of individual dose recommendation and is robust to the model misspecification and assumptions on the distribution of externally defined doses.



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Details

DokumentenartArtikel
Titel eines Journals oder einer ZeitschriftPharmaceutical Statistics
Verlag:Wiley
Band:21
Nummer des Zeitschriftenheftes oder des Kapitels:2
Seitenbereich:S. 476-495
Datum10 Dezember 2021
InstitutionenInformatik und Data Science > Fachbereich Maschinelles Lernen und Data Science > Chair for Computational Statistics (Prof. Dr. Thomas Jaki)
Identifikationsnummer
WertTyp
10.1002/pst.2181DOI
Stichwörter / Keywordsbaclofen combination trial dose individualisation dose-finding methadone opiate detoxification
Dewey-Dezimal-Klassifikation000 Informatik, Informationswissenschaft, allgemeine Werke > 004 Informatik
StatusVeröffentlicht
BegutachtetJa, diese Version wurde begutachtet
An der Universität Regensburg entstandenNein
URN der UB Regensburgurn:nbn:de:bvb:355-epub-778589
Dokumenten-ID77858

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