ArticleClinical trials (London, England)2017
Isotonic designs for phase I trials in partially ordered groups.
Article in Clinical trials (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- Phase I design for partially ordered groups with late-onset toxicity.Clinical trials (London, England) · 2026Article
- Isotonic Phase I cancer clinical trial design utilizing patient-reported outcomes.Statistics in biopharmaceutical research · 2025Article
- Adaptive Bayesian information borrowing methods for finding and optimizing subgroup-specific doses.Clinical trials (London, England) · 2024Review
- Review
- Bayesian Design for Identifying Cohort-Specific Optimal Dose Combinations Based on Multiple Endpoints: Application to a Phase I Trial in Non-Small Cell Lung Cancer.International journal of environmental research and public health · 2021Article
- Adapting isotonic dose-finding to a dynamic set of drug combinations with application to a phase I leukemia trial.Clinical trials (London, England) · 2021Article
- Consequences of Performing Parallel Dose Finding Trials in Heterogeneous Groups of Patients.JNCI cancer spectrum · 2019Article
- Shift models for dose-finding in partially ordered groups.Clinical trials (London, England) · 2019Article
- Revisiting isotonic phase I design in the era of model-assisted dose-finding.Clinical trials (London, England) · 2018Article
- A model-assisted design for partially or completely ordered groups.Pharmaceutical statisticsArticle
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Abstract
BACKGROUND/
aimsDose-finding trials can be conducted such that patients are first stratified into multiple risk groups before doses are allocated. The risk groups are often completely ordered in that, for a fixed dose, the probability of toxicity is monotonically increasing across groups. In some trials, the groups are only partially ordered. For example, one of several groups in a trial may be known to have the least risk of toxicity for a given dose, but the ordering of the risk among the remaining groups may not be known. The aim of the article is to introduce a method for designing dose-finding trials of cytotoxic agents in completely or partially ordered groups of patients.
methodsThis article presents a method for dose-finding that combines previously proposed mathematical models, augmented with results using order restricted inference. The resulting method is computationally convenient and allows for dose-finding in trials with completely or partially ordered groups. Extensive simulations are done to evaluate the performance of the method, using randomly generated dose-toxicity curves where, within each group, the risk of toxicity is an increasing function of dose.
resultsOur simulations show that the hybrid method, in which order-restricted estimation is applied to parameters of a parsimonious mathematical model, gives results that are similar to previously proposed methods for completely ordered groups. Our method generalizes to a wide range of partial orders among the groups.
conclusionThe problem of dose-finding in partially ordered groups has not been extensively studied in the statistical literature. The proposed method is computationally feasible, and provides a potential solution to the design of dose-finding studies in completely or partially ordered groups.
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