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PreprintarXiv licencearXiv

Transformer-Based Reinforcement Learning for Phase I Dose Allocation

Abstract

Phase I dose-finding trials must learn from sparse toxicity observations while limiting exposure to overly toxic doses. We develop a single reinforcement-learning policy for trials with different numbers of ordered dose levels. Each dose is represented as a token containing its normalized position, accumulated patient count, observed dose-limiting toxicities (DLTs), and current-dose indicator. A Transformer encoder summarizes the dose tokens, trial-conditioned cross-attention produces a fixed-dimensional trial representation, and a three-action policy chooses de-escalation, staying, or escalation. The final maximum tolerated dose (MTD) decision is deliberately kept outside the learned policy: after the planned sample size, weighted isotonic regression and a prespecified safety cap select the dose closest to the target toxicity probability. In the simulations, toxicity-penalized policies reduce DLT burden while unpenalized policies improve selection accuracy at the cost of greater toxicity. These results demonstrate a controllable safety--accuracy trade-off but do not establish superiority over conventional dose-finding designs.

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BibTeX
@misc{yuan2026transformerbased,
  title = {{Transformer-Based Reinforcement Learning for Phase I Dose Allocation}},
  author = {Shijie Yuan},
  howpublished = {arXiv},
  year = {2026},
  month = nov,
  doi = {10.48550/arxiv.2611.00395},
  eprint = {2611.00395},
  archivePrefix = {arXiv},
  url = {https://arxiv.org/abs/2611.00395},
}
RIS
TY  - UNPB
TI  - Transformer-Based Reinforcement Learning for Phase I Dose Allocation
AU  - Shijie Yuan
PY  - 2026
DA  - 2026/11/01
PB  - arXiv
DO  - 10.48550/arxiv.2611.00395
UR  - https://arxiv.org/abs/2611.00395
AB  - Phase I dose-finding trials must learn from sparse toxicity observations while limiting exposure to overly toxic doses. We develop a single reinforcement-learning policy for trials with different numbers of ordered dose levels. Each dose is represented as a token containing its normalized position, accumulated patient count, observed dose-limiting toxicities (DLTs), and current-dose indicator. A Transformer encoder summarizes the dose tokens, trial-conditioned cross-attention produces a fixed-dimensional trial representation, and a three-action policy chooses de-escalation, staying, or escalation. The final maximum tolerated dose (MTD) decision is deliberately kept outside the learned policy: after the planned sample size, weighted isotonic regression and a prespecified safety cap select the dose closest to the target toxicity probability. In the simulations, toxicity-penalized policies reduce DLT burden while unpenalized policies improve selection accuracy at the cost of greater toxicity. These results demonstrate a controllable safety--accuracy trade-off but do not establish superiority over conventional dose-finding designs.
ER  -