simFastBOIN
Design and evaluate phase I dose-finding trials that use the Bayesian optimal interval (BOIN) design of Liu and Yuan (2015) <doi:10.1111/rssc.12089>. Functions are provided to tabulate the decision boundaries, to simulate trials, to estimate the dose-toxicity curve under a monotonicity constraint and to select the maximum tolerated dose. The simulation engine is written in C++ and draws one random variate per patient in enrollment order, which reproduces the reference implementation in the 'BOIN' package trial by trial for a given seed. The traditional 3+3 design is provided as a comparator, with operating characteristics obtained in closed form rather than by simulation. For toxicity that is observed late, the time-to-event BOIN design is provided with the two estimators of Yuan and colleagues (2018) <doi:10.1158/1078-0432.CCR-18-0246> and Lin and Yuan (2020) <doi:10.1093/biostatistics/kxz007>. Patients who arrive while the dose escalation waits can be backfilled to lower doses with the designs of Zhao and colleagues (2024) <doi:10.1158/1078-0432.CCR-23-2585> and Chen and colleagues (2026) <doi:10.1007/s43441-026-00994-0>, the latter with the suspension rules of Chen and colleagues (2025) <doi:10.1158/1078-0432.CCR-24-3669>. Trials of two drugs given together are handled by the drug-combination design of Lin and Yin (2017) <doi:10.1177/0962280215594494>.
- Backfilling Patients in Phase I Dose-Escalation Trials Using Bayesian Optimal Interval Design (BOIN)
- Bayesian optimal interval design for dose finding in drug-combination trials
- Bayesian optimal interval designs for phase I clinical trials
- BE-BOIN: A Dose Optimization Design Accommodating Backfill and Late-Onset Toxicity
- Practical Considerations for Using the TITE-BOIN Design to Handle Late-Onset Toxicity or Fast Accrual in Phase I Trials
- Time-to-Event Bayesian Optimal Interval Design to Accelerate Phase I Trials
- Time-to-event model-assisted designs for dose-finding trials with delayed toxicity
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