期刊
PHARMACEUTICAL STATISTICS
卷 21, 期 2, 页码 476-495出版社
WILEY
DOI: 10.1002/pst.2181
关键词
baclofen; combination trial; dose individualisation; dose-finding; methadone; opiate detoxification
资金
- Medical Research Council [MC_UU_00002/14, MR/ T025557/1]
- National Institute for Health Research [NIHR-SRF-2015-08-001, NIHR300576, NIHR300593]
- NIHR Cambridge Biomedical Research Centre [BRC-1215-20014]
- National Institutes of Health Research (NIHR) [NIHR300576, NIHR300593] Funding Source: National Institutes of Health Research (NIHR)
There is a growing interest in early phase dose-finding clinical trials studying combinations of several treatments. The proposed design for a dual-agent combination trial motivated by an opiate detoxification trial results in high accuracy of individual dose recommendation and is robust to model misspecification and assumptions on the distribution of externally defined doses, as shown in a simulation study.
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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