ArticleBiostatistics (Oxford, England)2016
A robust Bayesian dose-finding design for phase I/II clinical trials.
Article in Biostatistics (Oxford, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers.
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Who cites it
37 citing papers in PubMed.
- Trial
- SCI: A Bayesian adaptive phase I/II dose-finding design accounting for semi-competing risks outcomes for immunotherapy trials.Pharmaceutical statistics · 2022Trial
- A Biomarker-Based Dose-Schedule Optimization Design for Immunotherapy Trials.Statistics in medicine · 2026Article
- Joint time-to-event partial order continual reassessment method and Joint time-to-event Bayesian logistic regression model: Statistical designs for dual agent phase I/II dose finding studies with late-onset toxicity and activity outcomes.Statistical methods in medical research · 2026Article
- A Bayesian pharmacokinetics integrated phase I-II design to optimize dose-schedule regimes.Biostatistics (Oxford, England) · 2025Article
- Using circulating tumor DNA as a novel biomarker of efficacy for dose-finding designs in oncology.Statistical methods in medical research · 2025Article
- Assessing the role of correlation between efficacy and toxicity endpoints in the performance of Bayesian optimal phase II design.Contemporary clinical trials · 2025Article
- UNITED: A Unified Transparent and Efficient Phase I/II Trial Design for Dose Optimization Accounting for Ordinal Graded, Continuous and Mixed Toxicity and Efficacy Endpoints.Statistics in medicine · 2025Article
- Joint TITE-CRM: A Design for Dose Finding Studies for Therapies with Late-Onset Safety and Activity Outcomes.Statistics in biopharmaceutical research · 2025Article
- REDOMA: Bayesian random-effects dose-optimization meta-analysis using spike-and-slab priors.Statistics in medicine · 2024Article
- A Bayesian latent-subgroup platform design for dose optimization.Biometrics · 2024Article
- A Bayesian quasi-likelihood design for identifying the minimum effective dose and maximum utility dose in dose-ranging studies.Statistical methods in medical research · 2024Article
- Adaptive phase I-II clinical trial designs identifying optimal biological doses for targeted agents and immunotherapies.Clinical trials (London, England) · 2024Review
- Statistical and practical considerations in planning and conduct of dose-optimization trials.Clinical trials (London, England) · 2024Review
- Dose optimization for cancer treatments with considerations for late-onset toxicities.Clinical trials (London, England) · 2024Article
- Modified isotonic regression based phase I/II clinical trial design identifying optimal biological dose.Contemporary clinical trials · 2023Article
- BAYESIAN HIERARCHICAL RANDOM-EFFECTS META-ANALYSIS AND DESIGN OF PHASE I CLINICAL TRIALS.The annals of applied statistics · 2022Article
- A software tool for both the maximum tolerated dose and the optimal biological dose finding trials in early phase designs.Contemporary clinical trials communications · 2022Article
- CFO: Calibration-free odds design for phase I/II clinical trials.Statistical methods in medical research · 2022Article
- TITE-BOIN12: A Bayesian phase I/II trial design to find the optimal biological dose with late-onset toxicity and efficacy.Statistics in medicine · 2022Article
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Authors and funding
2 authors.
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Abstract
We propose a Bayesian phase I/II dose-finding trial design that simultaneously accounts for toxicity and efficacy. We model the toxicity and efficacy of investigational doses using a flexible Bayesian dynamic model, which borrows information across doses without imposing stringent parametric assumptions on the shape of the dose-toxicity and dose-efficacy curves. An intuitive utility function that reflects the desirability trade-offs between efficacy and toxicity is used to guide the dose assignment and selection. We also discuss the extension of this design to handle delayed toxicity and efficacy. We conduct extensive simulation studies to examine the operating characteristics of the proposed method under various practical scenarios. The results show that the proposed design possesses good operating characteristics and is robust to the shape of the dose-toxicity and dose-efficacy curves.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.