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Background <p>While medications are essential for preventing and treating disease, they can also cause harm. Evidence synthesis has been widely adopted for evaluating harms, but traditional methods are resource-intensive and may constrain timely decision-making. This study aims to validate a Trial Bank approach towards rapid evidence synthesis.</p> Methods <p>A Trial Bank consisting of 13,650 RCTs of pharmaceutical or biopharmaceutical agents for children was established using artificial intelligence (AI) and humans, based on five databases (e.g., PubMed) up to February 14, 2023. The Trial Bank approach for evidence synthesis was validated in two ways: First, the percentage of trials within 1,996 Cochrane meta-analyses of drug safety in children that were also available in the Trial Bank was reported as the Trial Bank coverage (TBC). Second, the agreement of pooled effects from trials limited to those in the Trial Bank was compared to the full Cochrane meta-analyses in terms of their direction and statistical significance.</p> Results <p>Of 1,020 trials included in the Cochrane meta-analyses, there was an overall 80.2% TBC, with an average TBC of 85.7% per meta-analysis (<i>n</i> = 1,996). With regards to agreement of meta-analytical results, use of only the Trial Bank trials achieved an agreement of 93.0% (95% confidence interval [CI]: 90.8% to 94.8%) in the direction, 95.8% (95%CI: 94.0% to 97.2%) in significance, and 89.1% (95%CI: 94.0% to 97.2%) in both direction and significance to Cochrane meta-analytical results for meta-analyses that had 2 or more trials (<i>n</i> = 668). Sensitivity analysis by removing unpublished trials from Cochrane meta-analyses showed slightly higher agreement (e.g., 90.7% in both direction and significance).</p> Conclusions <p>The Trial Bank approach demonstrated considerable coverage and agreement with Cochrane meta-analyses, suggesting it is a potentially feasible and efficient strategy for supporting living evidence synthesis of medication safety in children.</p>

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The Trial Bank initiative to promote trustworthy living evidence for medication safety (PROMISE) of children: design and pilot validation

  • 期刊论文

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  • 发表日期：

    2026年2月21日

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  • Chang Xu,
  • Suhail A. Doi,
  • Sunita Vohra,
  • Luis Furuya-Kanamori,
  • Yingxia Wang,
  • Lijun Tang,
  • Yuan Tian,
  • Shiqi Fan,
  • Zhen Peng,
  • Evan Mayo-Wilson,
  • Lifeng Lin,
  • Haitao Chu,
  • M. Hassan Murad,
  • Tianqi Yu,
  • Sheyu Li,
  • Yaolong Chen,
  • Su Golder,
  • Yoon Loke,
  • Justin Clark,
  • Paul Glasziou,
  • Liang Du,
  • Houwen Lin,
  • Zhichun Gu,
  • Bichun Huang,
  • Changchang Chen,
  • Changchun He,
  • Chaoneng He,
  • Chenkai Xu,
  • Chenxia Hao,
  • Chunhui Li,
  • Chunxiao Wang,
  • Chunyan Mo,
  • Chunyu Zhang,
  • Dandan Xu,
  • Danni Xia,
  • Fali Zhang,
  • Fan Gao,
  • Fang Xie,
  • Fangfang Zuo,
  • Fangyi Qian,
  • Feifei Han,
  • Guifang Jin,
  • Haian Diao,
  • Hailan Wu,
  • Haixing Wang,
  • Hang Xin,
  • Haocheng Wang,
  • Haoning Zhu,
  • Hong Cao,
  • Hong Liu,
  • Hongtao Yang,
  • Hongting Chen,
  • Hongxin Shu,
  • Hui Zou,
  • Huoran Zhou,
  • Jiajie Huang,
  • Jiali Wu,
  • Jianzhou Liu,
  • Jiaojiao Kou,
  • Jiaojiao Zhao,
  • Jiazhen Wang,
  • Jie Wang,
  • Jihong Hu,
  • Jin Wang,
  • Jincheng Zhang,
  • Jing Ming,
  • Jingxi Feng,
  • Jingyi Wang,
  • Kai Liu,
  • Ke Zhou,
  • Keer Jiang,
  • Kexin Fu,
  • Kexin Gao,
  • Langyu Xiong,
  • Lei Qian,
  • Li Zhu,
  • Lijie Zhang,
  • Limin Li,
  • Ling Wang,
  • Lizi Hu,
  • Long Dao,
  • Manyu Zhang,
  • Mengxia Yan,
  • Mengxia Zhang,
  • Menya Zhao,
  • Mianhui Hong,
  • Mili Shi,
  • Min Gao,
  • Minhong Li,
  • Na He,
  • Ning Wang,
  • Qiang Zhou,
  • Qiannan Wang,
  • Qianqian Ji,
  • Ran Zhao,
  • Rui Zhang,
  • Ruoxi Wang,
  • Ruxin Zhang,
  • Shanshan Xu,
  • Shizhao Shi,
  • Shizhong Zhou,
  • Shouzhen Liu,
  • Shuting Xing,
  • Shuya Sun,
  • Si Gao,
  • Sizhe Li,
  • Songhong Xie,
  • Teng Yao,
  • Tongtong Miao,
  • Wanying Zhang,
  • Wei Du,
  • Weilong Zhao,
  • Weina Li,
  • Wenjing Qiang,
  • Wenqian Zhu,
  • Xi Yang,
  • Xianglin Zhang,
  • Xiangyun Li,
  • Xiaonuo Han,
  • Xiaowei Yang,
  • Xiaoya Sun,
  • Xiaoyu Wang,
  • Xiaoyuan Zheng,
  • Xin He,
  • Xin Qiao,
  • Xinke Ding,
  • Xinke Gao,
  • Xinxin Wu,
  • Xinyan Bu,
  • Xinyu Gao,
  • Xinyu Zhang,
  • XinYue Wang,
  • Yafang Hao,
  • Yafang Zheng,
  • Yanan Zheng,
  • Yanyan Dong,
  • Yanyan Pan,
  • Yi Zhu,
  • Yifei Wang,
  • Ying Zhao,
  • Yingjia Xu,
  • Yingying Zuo,
  • Yiwei Peng,
  • Yong Hong,
  • Yongjin Zhai,
  • Yuanyuan Wang,
  • Yueyue Wang,
  • Yueyue Zhang,
  • Yuhua He,
  • Yujuan Zhai,
  • Yukai Xu,
  • Yun Yin,
  • Yunyan Chen,
  • Yuqing Yang,
  • Yutong Cheng,
  • Yuxuan Guo,
  • Zhengyang Pan,
  • Zhenrong Ran,
  • Zhenshan Gao,
  • Zhicheng Guo,
  • Zhihui Jia,
  • Zhiyun Hu,
  • Zhuangzhuang Tang,
  • Zhuo Deng,
  • Zhuzhu Qin,
  • Zihan Shen

摘要

Background

While medications are essential for preventing and treating disease, they can also cause harm. Evidence synthesis has been widely adopted for evaluating harms, but traditional methods are resource-intensive and may constrain timely decision-making. This study aims to validate a Trial Bank approach towards rapid evidence synthesis.

Methods

A Trial Bank consisting of 13,650 RCTs of pharmaceutical or biopharmaceutical agents for children was established using artificial intelligence (AI) and humans, based on five databases (e.g., PubMed) up to February 14, 2023. The Trial Bank approach for evidence synthesis was validated in two ways: First, the percentage of trials within 1,996 Cochrane meta-analyses of drug safety in children that were also available in the Trial Bank was reported as the Trial Bank coverage (TBC). Second, the agreement of pooled effects from trials limited to those in the Trial Bank was compared to the full Cochrane meta-analyses in terms of their direction and statistical significance.

Results

Of 1,020 trials included in the Cochrane meta-analyses, there was an overall 80.2% TBC, with an average TBC of 85.7% per meta-analysis (n = 1,996). With regards to agreement of meta-analytical results, use of only the Trial Bank trials achieved an agreement of 93.0% (95% confidence interval [CI]: 90.8% to 94.8%) in the direction, 95.8% (95%CI: 94.0% to 97.2%) in significance, and 89.1% (95%CI: 94.0% to 97.2%) in both direction and significance to Cochrane meta-analytical results for meta-analyses that had 2 or more trials (n = 668). Sensitivity analysis by removing unpublished trials from Cochrane meta-analyses showed slightly higher agreement (e.g., 90.7% in both direction and significance).

Conclusions

The Trial Bank approach demonstrated considerable coverage and agreement with Cochrane meta-analyses, suggesting it is a potentially feasible and efficient strategy for supporting living evidence synthesis of medication safety in children.