Original Investigation

Large Language Model Analysis of Reporting Quality of Randomized Clinical Trial Articles

JAMA Network Open 10.1001/jamanetworkopen.2025.29418

August 28, 2025 at 11:00 AM EDT

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Can a zero-shot large-language-model (LLM) framework accurately assess Consolidated Standards for Reporting Trials (CONSORT) reporting in randomized clinical trials (RCTs), and what trends does it uncover?In this systematic review, an LLM performed well on 50 benchmark RCTs and then assessed 21 041 open-access RCTs, published from 1966 to 2024. Overall CONSORT compliance rose from 27% before 1990 to 57% after 2010, yet key methodological items remained poorly reported; compliance varied widely by biomedical discipline (35%-63%).These findings suggest that LLMs could enable scalable, reliable auditing of RCT reporting and highlight persistent gaps that journals and funders should target to improve research transparency and reproducibility.

Corresponding Authors: Nicholas P. Tatonetti, PhD (Nicholas.Tatonetti@cshs.org), and Apoorva Srinivasan, MS (Apoorva.Srinivasan@cshs.org), Department of Computational Biomedicine, Cedars-Sinai Medical Center, 8700 Beverly Blvd, Los Angeles, CA 90069.

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