Bayesian data augmentation dose finding with continual reassessment method and delayed toxicity
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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.
Recommendations
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Cites work
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- Sequential Designs for Phase I Clinical Trials with Late‐Onset Toxicities
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Cited in
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- Review of Statistical Treatment for Oncology Dose-Escalation Trial with Prolonged Evaluation Window or Fast Enrollment
- Application of gamma process to two-agent combinations with delayed toxicity
- BAGS: a Bayesian adaptive group sequential trial design with subgroup-specific survival comparisons
- A Bayesian adaptive phase I/II clinical trial design with late‐onset competing risk outcomes
- Biomarker-based precision dose finding for immunotherapy combined with radiotherapy
- Statistical frameworks for oncology dose-finding designs with late-onset toxicities: a review
- A nonparametric Bayesian method for dose finding in drug combinations cancer trials
- A utility-based Bayesian optimal interval (U-BOIN) phase I/II design to identify the optimal biological dose for targeted and immune therapies
- Early completion of phase I cancer clinical trials with Bayesian optimal interval design
- TITE-BOIN12: a Bayesian phase I/II trial design to find the optimal biological dose with late-onset toxicity and efficacy
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- PoD-BIN: a probability of decision Bayesian interval design for time-to-event dose-finding trials with multiple toxicity grades
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