在前性和后性COVID药物开发案例中进行可翻译性评分
Alexandra Wendler1, Martin Wehling2
1Clinical Pharmacology, Faculty of Medicine, Ruprecht-Karls-University of Heidelberg, 68167, Mannheim, Germany.
European journal of clinical pharmacology
|June 6, 2023
概括
一个新的可翻译性得分准确地预测了药物和疫苗开发的临床试验结果,显示了86%的预测值. 该工具有助于对生物医学行业的项目选择和风险管理.
科学领域:
- 生物医学研究生物医学研究
- 药物开发 药物开发
- 临床试验 临床试验
背景情况:
- COVID-19 流行病刺激了前所未有的临床研究,特别是在疫苗开发方面.
- 这种独特的情况允许对2009年翻译性评分进行前性评估.
研究的目的:
- 在临床试验结果中评估可翻译性得分的预测准确性.
- 评估评分在识别项目的优缺点方面的有用性.
主要方法:
- 选择的疫苗和治疗方法的第三期临床试验,用于转化评分.
- 进行了6个前性和6个后性案例研究.
- 进行了斯皮尔曼相关性和克鲁斯卡尔·沃利斯测试以进行统计分析.
主要成果:
- 在可翻译性得分和临床结果 (市场批准,终点成功) 之间发现了显著的相关性.
- 斯皮尔曼分析显示了强烈的相关性:r=0.91 (所有病例),r=0.93 (前性),r=0.93 (后性).
- 该得分显示,临床结果的预测准确率为86%.
结论:
- 翻译性评分有效地识别了项目的优点/缺点,使得有针对性的改进和组合风险平衡成为可能.
- 评分的预测价值对制药行业,资助机构和研究人员来说非常重要.
- 未来的研究应该探索针对特定治疗领域的概括性和适应性.
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