ArticleClinical cancer research : an official journal of the American Association for Cancer Research2018
Time-to-Event Bayesian Optimal Interval Design to Accelerate Phase I Trials.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 53 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis
An Early Feasibility Study to Evaluate the Safety of the TheraSphere Prostate Cancer (PCa) Device in Patients With Clinically Localized Prostate Cancer
Who cites it
53 citing papers in PubMed, 125 citations in OpenAlex.
- Surv-CRM-12: A Bayesian phase I/II survival CRM for right-censored toxicity endpoints with competing disease progression.Statistics in medicine · 2022Trial
- Novel clinical trial design and analytic methods to tackle challenges in therapeutic development in rare diseases.Annals of translational medicine · 2022Trial
- Phase I design for partially ordered groups with late-onset toxicity.Clinical trials (London, England) · 2026Article
- BE-BOIN: A Dose Optimization Design Accommodating Backfill and Late-Onset Toxicity.Therapeutic innovation & regulatory science · 2026Article
- Patient Retreat in Dose Escalation for Phase I Clinical Trials With Rare Diseases.Statistics in medicine · 2026Article
- A Bayesian pharmacokinetics integrated phase I-II design to optimize dose-schedule regimes.Biostatistics (Oxford, England) · 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
- Sequential monitoring of time-to-event safety endpoints in clinical trials.Clinical trials (London, England) · 2025Article
- CFO: Calibration-Free Odds Bayesian Designs for Dose Finding in Clinical Trials.JCO clinical cancer informatics · 2025Article
- Sitravatinib in combination with nivolumab plus ipilimumab in patients with advanced clear cell renal cell carcinoma: a phase 1 trial.Nature communications · 2025Article
- Isotonic Phase I cancer clinical trial design utilizing patient-reported outcomes.Statistics in biopharmaceutical research · 2025Article
- Comb-BOIN12: A Utility-Based Bayesian Optimal Interval Design for Dose Optimization in Cancer Drug-Combination Trials.Statistics in biopharmaceutical research · 2025Article
- Determining doses for backfill cohorts based on patient-reported outcome.BMC medical research methodology · 2024Article
- Tips for Accelerating BOIN Design.Therapeutic innovation & regulatory science · 2024Article
- Review
- MC-Keyboard: A Practical Phase I Trial Design for Targeted Therapies and Immunotherapies Integrating Multiple-Grade Toxicities.Journal of immunotherapy and precision oncology · 2024Article
- STRILL: Phase I Trial Evaluating Stereotactic Body Radiotherapy (SBRT) Dose Escalation for Re-Irradiation of Inoperable Peripheral Lung Lesions.Diseases (Basel, Switzerland) · 2024Article
- Dose optimization for cancer treatments with considerations for late-onset toxicities.Clinical trials (London, England) · 2024Article
- Safety, Tolerability, and Dose-Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis: Protocol for a Phase 1 Clinical Trial to Determine Safety and Identify Side Effects.JMIR research protocols · 2024Article
- Optimizing the FDA's Project Optimus: opportunities and challenges.Nature reviews. Clinical oncology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 2 countries.
Funding
Abstract
Late-onset toxicity is common for novel molecularly targeted agents and immunotherapy. It causes major logistic difficulty for existing adaptive phase I trial designs, which require the observance of toxicity early enough to apply dose-escalation rules for new patients. The same logistic difficulty arises when the accrual is rapid. We propose the time-to-event Bayesian optimal interval (TITE-BOIN) design to accelerate phase I trials by allowing for real-time dose assignment decisions for new patients while some enrolled patients' toxicity data are still pending. Similar to the rolling six design, the TITE-BOIN dose-escalation/deescalation rule can be tabulated before the trial begins, making it transparent and simple to implement, but is more flexible in choosing the target dose-limiting toxicity (DLT) rate and has higher accuracy to identify the MTD. Compared with the more complicated model-based time-to-event continuous reassessment method (TITE-CRM), the TITE-BOIN has comparable accuracy to identify the MTD but is simpler to implement with substantially better overdose control. As the TITE-CRM is more aggressive in dose escalation, it is less likely to underdose patients. When there are no pending data, the TITE-BOIN seamlessly reduces to the BOIN design. Numerical studies show that the TITE-BOIN design supports continuous accrual without sacrificing patient safety or the accuracy of identifying the MTD, and therefore has great potential to accelerate early-phase drug development.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.