ROBOTO2: An Interactive System and Dataset for LLM-assisted Clinical Trial Risk of Bias Assessment

Anthony Hevia, Sanjana Chintalapati, Veronica Ka Wai Lai, Nguyen Thanh Tam, Wai-Tat Wong, Terry P Klassen, Lucy Lu Wang


Abstract
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.
Anthology ID:
2025.emnlp-demos.2
Volume:
Proceedings of the 2025 Conference on Empirical Methods in Natural Language Processing: System Demonstrations
Month:
November
Year:
2025
Address:
Suzhou, China
Editors:
Ivan Habernal, Peter Schulam, Jörg Tiedemann
Venue:
EMNLP
SIG:
Publisher:
Association for Computational Linguistics
Note:
Pages:
12–25
Language:
URL:
https://preview.aclanthology.org/ingest-emnlp/2025.emnlp-demos.2/
DOI:
Bibkey:
Cite (ACL):
Anthony Hevia, Sanjana Chintalapati, Veronica Ka Wai Lai, Nguyen Thanh Tam, Wai-Tat Wong, Terry P Klassen, and Lucy Lu Wang. 2025. ROBOTO2: An Interactive System and Dataset for LLM-assisted Clinical Trial Risk of Bias Assessment. In Proceedings of the 2025 Conference on Empirical Methods in Natural Language Processing: System Demonstrations, pages 12–25, Suzhou, China. Association for Computational Linguistics.
Cite (Informal):
ROBOTO2: An Interactive System and Dataset for LLM-assisted Clinical Trial Risk of Bias Assessment (Hevia et al., EMNLP 2025)
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https://preview.aclanthology.org/ingest-emnlp/2025.emnlp-demos.2.pdf