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October 13, 2025Open Access

BE-BOIN: A Dose Optimization Design Accommodating Backfill and Late-Onset Toxicity

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The BE-BOIN method accommodates late-onset toxicity and enhances dose decision-making, aligning with FDA guidelines.

BE-BOIN effectively identifies both maximum tolerable dose and optimal biological dose in clinical trials, enhancing efficacy.
Simulation studies demonstrate that BE-BOIN significantly reduces trial duration, optimizing patient safety and treatment outcomes.
The design allows for backfilling patients during escalation, addressing both efficacy and late-onset toxicity concerns.
Guidance from the FDA underscores the shift toward optimizing risk and benefit through improved data collection.

Chen et al. (2025) studied this question.

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October 13, 2025Open Access

View Full Paper

Ask AI

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Authors

The BE-BOIN method accommodates late-onset toxicity and enhances dose decision-making, aligning with FDA guidelines.

BE-BOIN effectively identifies both maximum tolerable dose and optimal biological dose in clinical trials, enhancing efficacy.
Simulation studies demonstrate that BE-BOIN significantly reduces trial duration, optimizing patient safety and treatment outcomes.
The design allows for backfilling patients during escalation, addressing both efficacy and late-onset toxicity concerns.
Guidance from the FDA underscores the shift toward optimizing risk and benefit through improved data collection.

Chen et al. (2025) studied this question.

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