批准后的活动提供有关怀孕和哺乳期药物使用安全性的数据 - - 超速视角
Maria Fernanda Scantamburlo Fernandes1, Amalia Alexe2, Olatayo Apara3
1Eli Lilly, Indianapolis, USA. maria.scantamburlo_fernandes@lilly.com.
Therapeutic innovation & regulatory science
|March 17, 2025
概括
由于试验排除,孕妇和哺乳期妇女缺乏药物安全数据. 关于怀孕登记册和药物监督的批准后研究进展缓慢,这凸显了需要更快,更全面的安全监测的需要.
科学领域:
- 药监和药物安全 药监和药物安全
- 生殖健康 生殖健康
- 临床试验设计 临床试验设计
背景情况:
- 孕妇和哺乳期妇女经常被排除在临床试验之外,这在药物安全性数据中造成了关键的差距.
- 目前的批准后安全活动是标签的主要来源,但数据生成时间长,往往不足.
- 对这些人群进行批准后研究的监管指导和方法正在发展.
研究的目的:
- 在过去的11年中,对制药公司进行调查,以了解他们在药物安全性方面的批准后的做法.
- 评估审批后安全活动的常见类型和结果.
- 确定对更有效和更及时的监控策略的需求.
主要方法:
- 在TransCelerate BioPharma的会员公司分发了一份调查.
- 收集的数据集中在11年的妊娠和哺乳期安全相关的批准后活动.
- 分析包括活动类型,结果和时间表.
主要成果:
- 所有被调查的公司都开展了对怀孕的批准后活动,怀孕登记是最常见的,其次是数据库研究和加强药物监督.
- 这些活动导致了处方信息的更新,但往往是经过多年的时间.
- 在哺乳期报告的批准后活动较少,报告结果有限.
结论:
- 对于怀孕和哺乳期的现有批准后安全活动是耗时的,并且为及时的临床决策提供了不足的数据.
- 显然需要采用全面的,多方面的方法,利用多种数据源,以便有效和及时地进行审批后监督.
- 改进的策略对于有效地描述孕妇和哺乳期患者的药物安全性至关重要.
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