Bayesian phase I/II adaptively randomized oncology trials with combined drugs
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Publication:641145
DOI10.1214/10-AOAS433zbMATH Open1232.62155arXiv1108.1614WikidataQ41545724 ScholiaQ41545724MaRDI QIDQ641145FDOQ641145
Authors: Ying Yuan, Guosheng Yin 
Publication date: 21 October 2011
Published in: The Annals of Applied Statistics (Search for Journal in Brave)
Abstract: We propose a new integrated phase I/II trial design to identify the most efficacious dose combination that also satisfies certain safety requirements for drug-combination trials. We first take a Bayesian copula-type model for dose finding in phase I. After identifying a set of admissible doses, we immediately move the entire set forward to phase II. We propose a novel adaptive randomization scheme to favor assigning patients to more efficacious dose-combination arms. Our adaptive randomization scheme takes into account both the point estimate and variability of efficacy. By using a moving reference to compare the relative efficacy among treatment arms, our method achieves a high resolution to distinguish different arms. We also consider groupwise adaptive randomization when efficacy is late-onset. We conduct extensive simulation studies to examine the operating characteristics of the proposed design, and illustrate our method using a phase I/II melanoma clinical trial.
Full work available at URL: https://arxiv.org/abs/1108.1614
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Applications of statistics to biology and medical sciences; meta analysis (62P10) Medical applications (general) (92C50)
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Cited In (22)
- Combining Information from Cancer Registry and Medical Records Data to Improve Analyses of Adjuvant Cancer Therapies
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- Cancer phase I trial design using drug combinations when a fraction of dose limiting toxicities is attributable to one or more agents
- A three-stage Bayesian adaptive phase I/II design and simulation studies
- Bayesian dose regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics
- A Bayesian decision‐theoretic approach to incorporate preclinical information into phase I oncology trials
- Adaptive oncology Phase I trial design of drug combinations with drug-drug interaction modeling
- ComPAS: a Bayesian drug combination platform trial design with adaptive shrinkage
- A Bayesian adaptive marker-stratified design for molecularly targeted agents with customized hierarchical modeling
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- A Bayesian adaptive design for addressing correlated late-onset outcomes in phase I/II randomized trials of drug combinations in oncology
- Bayesian phase II adaptive randomization by jointly modeling time-to-event efficacy and binary toxicity
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- A Bayesian adaptive phase I/II clinical trial design with late‐onset competing risk outcomes
- Bayesian hierarchical random-effects meta-analysis and design of phase I clinical trials
- Bootstrap aggregating continual reassessment method for dose finding in drug-combination trials
- Adaptive designs for selecting drug combinations based on efficacy-toxicity response
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