An artificial intelligence-based clinical trial inclusion and exclusion criterion formulation system and method

By integrating multi-source data and using artificial intelligence algorithms, the problem of insufficient subjective experience of experts in the formulation of inclusion and exclusion criteria for clinical trials has been solved, enabling the formulation of scientific and reasonable inclusion and exclusion criteria, improving the homogeneity of the enrolled population and the reliability of trial results, and adapting to the rapidly iterative needs of biomedical research and development.

CN122417463APending Publication Date: 2026-07-17SHANGHAI UNIV OF ENG SCI
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Patent Information

Application Number
CN202610218240.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-02-24
Publication Date
2026-07-17

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Abstract

本发明涉及一种基于人工智能的临床试验纳排标准制定系统,属于临床试验技术领域,通过多源数据整合与AI量化分析,替代专家主观经验,条款设置基于客观数据关联规律,核心特征无遗漏、阈值精准,入组人群同质性大幅提升,试验结果的可靠性与重复性增强;AI算法自动完成数据处理、条款生成、冲突检测,多中心协同通过数字化平台实现,制定周期缩短。本发明系统性整合真实世界数据(RWD)、历史临床试验数据、生物标志物数据、循证医学文献等多源异构数据,基于有限样本与文献决策,反映真实人群特征与指标关联规律。
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