当团体被遗忘时
Journal of the American Academy of Child and Adolescent Psychiatry
|December 24, 2025
概括
儿科药物开发往往被忽视,很少有FDA批准的药物适用于儿童. 这一倡导活动强调了需要将儿童纳入关键药物试验和批准的必要性.
科学领域:
- 儿科药理学 儿科药理学
- 药物开发 药物开发
- 临床试验 临床试验
背景情况:
- 药房和治疗委员会审查药物,并注意到FDA批准的儿童病症指标存在重大差距.
- 儿童和青少年精神病医生和儿科医生往往是这些委员会中儿科利益的唯一代表.
- 许多药物被开发和批准仅供成人使用,尽管它们可能与儿科疾病有关.
研究的目的:
- 为了突出药物开发和FDA批准对儿科和成年人群的差异.
- 倡导将儿童纳入关键药物试验和随后的批准过程.
- 强调需要解决在制药研究中对儿科患者的监督问题.
主要方法:
- 在药品和治疗委员会内对药物审查过程的分析.
- 对缺乏儿科特异性药物指示 (即缺乏儿科试验) 背后的理由的观察.
- 在药物开发决策中忽视儿童的影响的定性评估.
主要成果:
- 相当多的药物缺乏FDA批准的儿童用药物,即使它们可能有益.
- 这种缺陷的主要原因是,在药物开发过程中将儿童排除在临床试验之外.
- 这种监督导致儿童可能被拒绝获得必要的治疗.
结论:
- 在药物开发和批准过程中,儿童经常被忽视.
- 儿童和青少年精神病医生必须充当倡导者,以确保满足儿科需求.
- 需要在医学研究中更广泛地纳入包括儿童在内的代表性不足的群体.
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