Bayesian data augmentation dose finding with continual reassessment method and delayed toxicity

DOI10.1214/13-AOAS661MaRDI QIDQ2441853zbMATH OpenOpenAlexWikidataFDO

Authors Suyu Liu, Guosheng Yin, Ying Yuan

Publication date 28 March 2014

Published in The Annals of Applied Statistics (Search for Journal in Brave)

Full work available at URL https://arxiv.org/abs/1401.1706, https://projecteuclid.org/euclid.aoas/1387823313

zbMATH Keywords

phase I clinical trialsnon-ignorable missing datalate-onset toxicityBayesian adaptive design

Mathematics Subject Classification ID

Bayesian inference (62F15) Applications of statistics to biology and medical sciences; meta analysis (62P10) Medical applications (general) (92C50)

Abstract: A major practical impediment when implementing adaptive dose-finding designs is that the toxicity outcome used by the decision rules may not be observed shortly after the initiation of the treatment. To address this issue, we propose the data augmentation continual reassessment method (DA-CRM) for dose finding. By naturally treating the unobserved toxicities as missing data, we show that such missing data are nonignorable in the sense that the missingness depends on the unobserved outcomes. The Bayesian data augmentation approach is used to sample both the missing data and model parameters from their posterior full conditional distributions. We evaluate the performance of the DA-CRM through extensive simulation studies and also compare it with other existing methods. The results show that the proposed design satisfactorily resolves the issues related to late-onset toxicities and possesses desirable operating characteristics: treating patients more safely and also selecting the maximum tolerated dose with a higher probability. The new DA-CRM is illustrated with two phase I cancer clinical trials.

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Cites work

• scientific article; zbMATH DE number 1834445 (Why is no real title available?)
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• Robust EM continual reassessment method in oncology dose finding
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Cited in

(14)

• Biomarker-based precision dose finding for immunotherapy combined with radiotherapy
• Statistical frameworks for oncology dose-finding designs with late-onset toxicities: a review
• A utility-based Bayesian optimal interval (U-BOIN) phase I/II design to identify the optimal biological dose for targeted and immune therapies
• TITE-BOIN12: a Bayesian phase I/II trial design to find the optimal biological dose with late-onset toxicity and efficacy
• Time-to-event continual reassessment method incorporating treatment cycle information with application to an oncology phase I trial
• BAGS: a Bayesian adaptive group sequential trial design with subgroup-specific survival comparisons
• A nonparametric Bayesian method for dose finding in drug combinations cancer trials
• Early completion of phase I cancer clinical trials with Bayesian optimal interval design
• A phase I-II basket trial design to optimize dose-schedule regimes based on delayed outcomes
• Review of Statistical Treatment for Oncology Dose-Escalation Trial with Prolonged Evaluation Window or Fast Enrollment
• Bayesian data augmentation dose finding with continual reassessment method and delayed toxicity
• A Bayesian adaptive phase I/II clinical trial design with late‐onset competing risk outcomes
• Robust EM continual reassessment method in oncology dose finding
• Application of gamma process to two-agent combinations with delayed toxicity

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