ArticlePharmaceutical statistics2017
A simulation study of methods for selecting subgroup-specific doses in phase 1 trials.
Article in Pharmaceutical statistics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
7 citing papers in PubMed.
- Challenges, opportunities, and innovative statistical designs for precision oncology trials.Annals of translational medicine · 2022Trial
- Phase I/II Design for Selecting Subgroup-Specific Optimal Biological Doses for Prespecified Subgroups.Statistics in medicine · 2024Article
- Adaptive Bayesian information borrowing methods for finding and optimizing subgroup-specific doses.Clinical trials (London, England) · 2024Review
- The Correlated Beta Dose Optimisation Approach: Optimal Vaccine Dosing Using Mathematical Modelling and Adaptive Trial Design.Vaccines · 2022Article
- A Phase I-II Basket Trial Design to Optimize Dose-Schedule Regimes Based on Delayed Outcomes.Bayesian analysis · 2021Article
- A nonparametric Bayesian continual reassessment method in single-agent dose-finding studies.BMC medical research methodology · 2018Article
- Subgroup-specific dose finding in phase I clinical trials based on time to toxicity allowing adaptive subgroup combination.Pharmaceutical statistics · 2018Article
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
Patient heterogeneity may complicate dose-finding in phase 1 clinical trials if the dose-toxicity curves differ between subgroups. Conducting separate trials within subgroups may lead to infeasibly small sample sizes in subgroups having low prevalence. Alternatively,it is not obvious how to conduct a single trial while accounting for heterogeneity. To address this problem,we consider a generalization of the continual reassessment method on the basis of a hierarchical Bayesian dose-toxicity model that borrows strength between subgroups under the assumption that the subgroups are exchangeable. We evaluate a design using this model that includes subgroup-specific dose selection and safety rules. A simulation study is presented that includes comparison of this method to 3 alternative approaches,on the basis of nonhierarchical models,that make different types of assumptions about within-subgroup dose-toxicity curves. The simulations show that the hierarchical model-based method is recommended in settings where the dose-toxicity curves are exchangeable between subgroups. We present practical guidelines for application and provide computer programs for trial simulation and conduct.
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