美国食品和药物管理局的监管调整加速了传染病的途径:十年审查与预测建模见解
Nguyen Thanh Tam1, Ahmed M Sayed2,3, Mohammad Najm Dadam4,5
1School of Tropical Medicine and Global Health (TMGH), Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan.
Scientific reports
|December 13, 2025
概括
对传染病的药物开发速度比对非传染病的药物开发速度更快,但这些治疗方法的优先审查率较低. 政策改革是必要的,以促进抗感染创新和解决经济障碍.
科学领域:
- 药物经济学 药物经济学
- 药物开发 药物开发
- 监管科学 监管科学
背景情况:
- 传染病对全球健康构成重大威胁,但与瘤或孤儿疾病相比,对监管优先级的担忧仍然存在.
- 了解药物开发和批准时间表对于应对全球卫生挑战至关重要.
研究的目的:
- 为了比较传染病和非传染病之间的药物开发和批准生产率.
- 分析不同疾病类别的监管加速计划的利用模式.
主要方法:
- 一项横截面研究分析了2015年1月1日至2024年12月31日期间批准的464种药物和生物产品.
- 来自Drugs@FDA,联邦注册局和ClinicalTrials.gov的数据被用于计算中位数临床开发时间 (CDT),监管批准时间 (RAT) 和累计监管审查时间 (RRT).
- 统计分析包括Kruskal-Wallis,chi-square,Kaplan-Meier和多变量后勤回归来比较时间表和评估程序利用率.
主要成果:
- 与非传染病治疗相比,传染病治疗的中位数CDT (2.76与3.46年) 和RRT (3.54与4.22年) 显著缩短,而非传染病治疗的中位数CDT则显著缩短.
- 传染病剂的批准速度总体上快了58%.
- 虽然更有可能获得快速跟踪和优先审查名称,但传染病产品不太可能获得突破性治疗或加速批准.
结论:
- 传染病治疗显示出更快的开发和批准时间表,但未充分利用某些加速途径,如加速批准.
- 科学适用性和经济因素可能会影响用于传染病的特定监管途径的使用.
- 建议进行政策改革,以解决阻碍抗感染创新的经济和科学障碍.
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