0

$\texttt{AMEND++}$: 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…

Preview
Year
2026
Hosting
Full text hostedCC-BY-4.0

Cite

Notes

Only stored in your browser.

Attribution

Abstract & full text
arxiv.org/abs/2601.06300CC-BY-4.0
TL;DR
Semantic Scholar
Attribution policy →

Abstract

Clinical trial amendments frequently introduce delays, increased costs, and administrative burden, with eligibility criteria being the most commonly amended component. We introduce 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 AMEND++, a benchmark suite comprising two datasets: 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 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.