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原文摘要

AI is used in much of the clinical trial pipeline. However, selecting the statistical design of a trial, a crucial step that determines how drug doses are tested on humans and evaluated, has seen almost no AI progress. LLMs appear to be a natural fit given their strengths in biomedical knowledge and statistical reasoning. Nevertheless, there is currently no appropriate way to evaluate such abilities because recent regulatory and methodological shifts, most notably FDA's Project Optimus, have redefined what constitutes a reasonable design and rendered many previous designs obsolete. To lay the groundwork for AI-assisted trial design, we introduce TrialDesignBench, a benchmark of 617 Phase-I/I-II oncology dose-finding trials, each paired with an expert-validated reference design that is consistent with the latest FDA regulatory initiatives. This reference standard is produced through a formalization of the expert design process. We evaluate five frontier LLMs, none of which matches the reference standard. Our ablation experiments trace this performance gap to two main causes, inference of latent, unrecorded design determinants from trial sources (supplying them raises class-wise balanced accuracy by 0.22) and structured decision-tree reasoning (+0.24). TrialDesignBench offers a reproducible, contemporary-standard objective for evaluating and enhancing AI-assisted trial design.