Trisha Das
Publications
POET: Protocol Optimization via Eligibility Tuning
Eligibility criteria (EC) are essential for clinical trial design, yet drafting them remains a time-intensive and cognitively demanding task for clinicians. Existing automated approaches often fall at two extremes either requiring highly structured inputs, such as predefined entities to generate specific criteria, or relying on end-to-end systems that produce full eligibility criteria from minimal input such as trial descriptions limiting their practical utility. In this work, we propose a guided generation framework that introduces interpretable semantic axes, such as Demographics, Laboratory Parameters, and Behavioral Factors, to steer EC generation. These axes, derived using large language models, offer a middle ground between specificity and usability, enabling clinicians to guide generation without specifying exact entities. In addition, we present a reusable rubric-based evaluation framework that assesses generated criteria along clinically meaningful dimensions. Our results show that our guided generation approach consistently outperforms unguided generation in both automatic, rubric-based and clinician evaluations, offering a practical and interpretable solution for AI-assisted trial design.
$\texttt{AMEND++}$: Benchmarking Eligibility Criteria Amendments in Clinical Trials
Clinical trial amendments frequently introduce delays, increased costs, and administrative burden, with eligibility criteria being the most commonly amended component. We introduce \textit{eligibility criteria amendment prediction}, a novel NLP task that aims to forecast whether the eligibility criteria of an initial trial protocol will undergo future amendments. To support this task, we release $\texttt{AMEND++}$, a benchmark suite comprising two datasets: $\texttt{AMEND}$, which captures eligibility-criteria version histories and amendment labels from public clinical trials, and $\verb|AMEND_LLM|$, a refined subset curated using an LLM-based denoising pipeline to isolate substantive changes. We further propose $\textit{Change-Aware Masked Language Modeling}$ (CAMLM), a revision-aware pretraining strategy that leverages historical edits to learn amendment-sensitive representations. Experiments across diverse baselines show that CAMLM consistently improves amendment prediction, enabling more robust and cost-effective clinical trial design.