ArticleStatistics in medicine2022
TITE-BOIN12: A Bayesian phase I/II trial design to find the optimal biological dose with late-onset toxicity and efficacy.
Article in Statistics in medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
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Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Immune-Based Therapies in Pancreatic Cancer: a Systematic Review of Ongoing Clinical Trials (2020-2022).Journal of gastrointestinal cancer · 2025Pooled it
- Implementing Project Optimus in Oncology Dosage Optimization: Where are We Now?Therapeutic innovation & regulatory science · 2026Article
- Clinical Development of Novel-Novel Multi-Company Combination Therapies in Oncology.Current oncology reports · 2026Review
- 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 narrative review of adaptive Phase I/II clinical trial designs for drug combinations in oncology.Frontiers in oncology · 2026Review
- A robust Bayesian dose optimization design with backfill and randomization for phase I/II clinical trials.Statistical methods in medical research · 2025Article
- Using circulating tumor DNA as a novel biomarker of efficacy for dose-finding designs in oncology.Statistical methods in medical research · 2025Article
- Practical Considerations for Using the TITE-BOIN Design to Handle Late-Onset Toxicity or Fast Accrual in Phase I Trials.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Article
- COMIC: A Bayesian Dose Optimization Design for Drug Combination in Multiple Indications With Application to CAR-T Therapies.Statistics in medicine · 2025Article
- Comb-BOIN12: A Utility-Based Bayesian Optimal Interval Design for Dose Optimization in Cancer Drug-Combination Trials.Statistics in biopharmaceutical research · 2025Article
- Challenges and Lessons Learned in Autologous Chimeric Antigen Receptor T-Cell Therapy Development from a Statistical Perspective.Therapeutic innovation & regulatory science · 2024Article
- Dose optimization for cancer treatments with considerations for late-onset toxicities.Clinical trials (London, England) · 2024Article
- Statistical and practical considerations in planning and conduct of dose-optimization trials.Clinical trials (London, England) · 2024Review
- Adaptive phase I-II clinical trial designs identifying optimal biological doses for targeted agents and immunotherapies.Clinical trials (London, England) · 2024Review
- Comparison Between Simultaneous and Sequential Utilization of Safety and Efficacy for Optimal Dose Determination in Bayesian Model-Assisted Designs.Therapeutic innovation & regulatory science · 2023Article
- An overview of the BOIN design and its current extensions for novel early-phase oncology trials.Contemporary clinical trials communications · 2022Review
- Dosing Regimens of Immune Checkpoint Inhibitors: Attempts at Lower Dose, Less Frequency, Shorter Course.Frontiers in oncology · 2022Review
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7 authors.
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Abstract
In the era of immunotherapies and targeted therapies, the focus of early phase clinical trials has shifted from finding the maximum tolerated dose to identifying the optimal biological dose (OBD), which maximizes the toxicity-efficacy trade-off. One major impediment to using adaptive designs to find OBD is that efficacy or/and toxicity are often late-onset, hampering the designs' real-time decision rules for treating new patients. To address this issue, we propose the model-assisted TITE-BOIN12 design to find OBD with late-onset toxicity and efficacy. As an extension of the BOIN12 design, the TITE-BOIN12 design also uses utility to quantify the toxicity-efficacy trade-off. We consider two approaches, Bayesian data augmentation and an approximated likelihood method, to enable real-time decision making when some patients' toxicity and efficacy outcomes are pending. Extensive simulations show that, compared to some existing designs, TITE-BOIN12 significantly shortens the trial duration while having comparable or higher accuracy to identify OBD and a lower risk of overdosing patients. To facilitate the use of the TITE-BOIN12 design, we develop a user-friendly software freely available at http://www.trialdesign.org.
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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.