特刊"干细胞生物学与再生医学"
1BGU-iPSC Core Facility, The Regenerative Medicine & Stem Cell (RMSC) Research Center, Ben Gurion University of the Negev, Israel and Desert & Dead Sea R&D, Central Arava Branch, Be'er Sheva 84105, Israel.
International journal of molecular sciences
|August 26, 2023
概括
大多数临床前药物发现研究都失败了,浪费了资源. 改善动物模型对于成功开发药物和降低成本至关重要.
科学领域:
- 药理学和毒理学 药理学和毒理学
- 临床前研究方法学
背景情况:
- 药物发现管道是漫长而昂贵的.
- 超过50%的临床前研究未能转化为临床成功.
- 动物模型被广泛使用,但在预测人类反应方面存在局限性.
研究的目的:
- 分析临床前研究高失败率背后的原因.
- 确定当前动物模型在预测人类反应方面的局限性.
- 提出提高临床前研究翻译有效性的策略.
主要方法:
- 临床前研究结果的系统审查.
- 对动物模型数据与临床试验结果进行比较分析.
- 对影响研究成功或失败的因素的元分析.
主要成果:
- 临床前研究显示成功率低于50%.
- 在动物模型预测和人类结果之间存在显著的差异.
- 导致失败的关键因素包括不良的模型选择和缺乏机制理解.
结论:
- 目前的临床前模型对药物疗效的预测价值有限.
- 加强翻译性研究对于减少药物发现磨损至关重要.
- 未来的努力应集中在开发更具预测性的模型和强大的研究设计上.
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