同时的全球药物开发和多区域临床试验 (MRCT):ICH E17指南实施5年后
Rominder Singh1, William Wang2, Aloka Chakravarty3
1Pfizer Research and Development, 10555 Science Center Dr, San Diego, CA, 92121, USA. drugdevpro@gmail.com.
Therapeutic innovation & regulatory science
|May 12, 2024
概括
ICH E17指南通过多区域临床试验 (MRCT) 促进全球药物开发. 然而,关键概念的缓慢采用,如聚合策略,可能会阻碍全球患者及时获得新疗法.
科学领域:
- 制药科学 制药科学
- 临床试验管理 临床试验管理
- 监管事务 监管事务
背景情况:
- 国际协调委员会 (ICH) E17指南旨在通过多区域临床试验 (MRCT) 简化全球药物开发.
- 这些指导方针有助于同时开发和注册药物,减少重复和监管负担.
- 尽管有推广,但MRCT核心概念的采用,如聚合策略,一直很缓慢.
研究的目的:
- 确定和描述影响全球实施ICH E17指南MRCT的因素.
- 分析影响多区域临床试验成功进行的挑战.
- 为缓慢采用特定的MRCT战略提供见解.
主要方法:
- 审查ICH E17指南和相关培训材料.
- 分析影响MRCT行为因素,包括监管,运营和外部影响.
- 在MRCT中讨论案例研究和现实世界的数据应用.
主要成果:
- 对于MRCT来说,定义"地区"的模糊性是一个挑战.
- 对不同患者群体的新要求影响了试验设计和招生.
- 像去中心化临床试验 (DCT) 和真实世界数据 (RWD) 这样的新兴趋势为MRCT提供了机遇和复杂性.
- 由于COVID-19的流行,全球MRCT的运作受到严重破坏.
结论:
- 通过MRCT成功的全球药物开发需要解决定义的模糊性,并适应不断变化的监管环境.
- 整合多样化的患者群体和新的试验方法,如DCT和RWD,对于未来的MRCT成功至关重要.
- 克服实施障碍至关重要,以充分实现ICH E17指南对患者获取药物的好处.
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