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:
- 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)
- PDF:
- https://preview.aclanthology.org/ingest-emnlp/2025.emnlp-demos.2.pdf