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A dose-finding design for dual-agent trials with patient-specific doses for one agent with application to an opiate detoxification trial
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Pharmaceutical Statistics-2021-Mozgunov-A dose2010finding design for dual2010agent trials with patient2010specific doses for.pdf | Published version | 1.63 MB | Adobe PDF | View/Open |
Title: | A dose-finding design for dual-agent trials with patient-specific doses for one agent with application to an opiate detoxification trial |
Authors: | Mozgunov, P Cro, S Lingford-Hughes, A Paterson, LM Jaki, T |
Item Type: | Journal Article |
Abstract: | 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. |
Issue Date: | 1-Mar-2022 |
Date of Acceptance: | 21-Nov-2021 |
URI: | http://hdl.handle.net/10044/1/93122 |
DOI: | 10.1002/pst.2181 |
ISSN: | 1539-1604 |
Publisher: | John Wiley and Sons |
Start Page: | 476 |
End Page: | 495 |
Journal / Book Title: | Pharmaceutical Statistics: the journal of applied statistics in the pharmaceutical industry |
Volume: | 21 |
Issue: | 2 |
Copyright Statement: | © 2021 The Authors. Pharmaceutical Statistics published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
Sponsor/Funder: | Medical Research Council (MRC) |
Funder's Grant Number: | MR/T025557/1 |
Keywords: | Science & Technology Life Sciences & Biomedicine Physical Sciences Pharmacology & Pharmacy Statistics & Probability Mathematics baclofen combination trial dose individualisation dose-finding methadone opiate detoxification DRUG-COMBINATION baclofen combination trial dose individualisation dose-finding methadone opiate detoxification baclofen combination trial dose individualisation dose-finding methadone opiate detoxification Statistics & Probability 0104 Statistics 1115 Pharmacology and Pharmaceutical Sciences |
Publication Status: | Published |
Conference Place: | England |
Online Publication Date: | 2021-12-10 |
Appears in Collections: | Faculty of Medicine School of Public Health Department of Brain Sciences |
This item is licensed under a Creative Commons License