Shirui Wang, Zhihui Tang, Huaxia Yang, Qiuhong Gong, Tiantian Gu, Hongyang Ma, Yongxin Wang, Wubin Sun, Zeliang Lian, Kehang Mao, Yinan Jiang, Zhicheng Huang, Lingyun Ma, W D Shen, Yajie Ji, Yunhui Tan, Chunbo Wang, Yunlu Gao, Qianling Ye, Rui Lin, MingYu Chen, Lijuan Niu, Zhihao Wang, Peng Yu, Mengran Lang, Yue Liu, Huimin Zhang, Haitao Shen, Long Chen, Q M Zhao, Si-Xuan Liu, Lina Zhou, He Gao, Dongqiang Ye, Lingmin Meng, Youtao Yu, Nan Liang, Jianxiong Wu
Large language models (LLMs) hold promise in clinical decision support but face major challenges in safety evaluation and effectiveness validation. We developed the Clinical Safety-Effectiveness Dual-Track Benchmark (CSEDB), a multidimensional framework built on clinical expert consensus, encompassing 30 metrics covering critical areas like critical illness recognition, guideline adherence, and medication safety, with weighted consequence measures. Thirty-two specialist physicians developed and revised 2069 open-ended Q&A items aligned with these criteria, spanning 26 clinical departments to simulate real-world scenarios. Benchmark testing of six LLMs revealed moderate overall performance (average total score 57.2%, safety 54.7%, effectiveness 62.3%), with a significant 13.3% performance drop in high-risk scenarios (p < 0.0001). Domain-specific medical LLMs showed consistent performance advantages over general-purpose models, with relatively higher top scores in safety (0.912) and effectiveness (0.861). The findings of this study not only provide a standardized metric for evaluating the clinical application of medical LLMs, facilitating comparative analyses, risk exposure identification, and improvement directions across different scenarios, but also hold the potential to promote safer and more effective deployment of large language models in healthcare environments.