A dose-finding design for dual-agent trials with patient-specific doses for one agent with application to an opiate detoxification trial.
Publication Date
2022-03Journal Title
Pharm Stat
ISSN
1539-1604
Publisher
Wiley
Language
en
Type
Article
This Version
AO
VoR
Metadata
Show full item recordCitation
Mozgunov, P., Cro, S., Lingford-Hughes, A., Paterson, L. M., & Jaki, T. (2022). A dose-finding design for dual-agent trials with patient-specific doses for one agent with application to an opiate detoxification trial.. Pharm Stat https://doi.org/10.1002/pst.2181
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.
Keywords
MAIN PAPER, MAIN PAPERS, baclofen, combination trial, dose individualisation, dose‐finding, methadone, opiate detoxification
Sponsorship
NIHR Academy (SRF-2015-08-001)
Medical Research Council (MC_UU_00002/14)
National Institute for Health Research (IS-BRC-1215-20014)
Identifiers
pst2181
External DOI: https://doi.org/10.1002/pst.2181
This record's URL: https://www.repository.cam.ac.uk/handle/1810/331876
Rights
Licence:
http://creativecommons.org/licenses/by/4.0/
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