Anthony Hevia
2025
ROBOTO2: An Interactive System and Dataset for LLM-assisted Clinical Trial Risk of Bias Assessment
Anthony Hevia
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Sanjana Chintalapati
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Veronica Ka Wai Lai
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Nguyen Thanh Tam
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Wai-Tat Wong
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Terry P Klassen
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Lucy Lu Wang
Proceedings of the 2025 Conference on Empirical Methods in Natural Language Processing: System Demonstrations
We present ROBoto2, an open-source, web-based platform for large language model (LLM)-assisted risk of bias (ROB) assessment of clinical trials. ROBoto2 streamlines the traditionally labor-intensive ROB v2 (ROB2) annotation process via an interactive interface that combines PDF parsing, retrieval-augmented LLM prompting, and human-in-the-loop review. Users can upload clinical trial reports, receive preliminary answers and supporting evidence for ROB2 signaling questions, and provide real-time feedback or corrections to system suggestions. ROBoto2 is publicly available at https://roboto2.vercel.app/, with code and data released to foster reproducibility and adoption. We construct and release a dataset of 521 pediatric clinical trial reports (8954 signaling questions with 1202 evidence passages), annotated using both manually and LLM-assisted methods, serving as a benchmark and enabling future research. Using this dataset, we benchmark ROB2 performance for 4 LLMs and provide an analysis into current model capabilities and ongoing challenges in automating this critical aspect of systematic review.
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- Sanjana Chintalapati 1
- Terry P Klassen 1
- Veronica Ka Wai Lai 1
- Nguyen Thanh Tam 1
- Lucy Lu Wang 1
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