关于FDA药物和医疗器械监管的健康专业学生的知识
Kiranjot K Sangha1, Rita F Redberg2, Aaron S Kesselheim3
1K.K. Sangha was a medical student, University of California San Francisco, San Francisco, California, at the time of this writing and is now a resident physician, Department of Medicine, University of California Irvine, Irvine, California.
概括
最后一年的医疗专业学生对食品和药物管理局 (FDA) 的规定和临床试验解释缺乏理解. 需要加强对这些关键主题的教育, 以改善患者对药物和医疗器械的护理决策.
科学领域:
- 医疗教育
- 监管科学
- 临床研究
背景情况:
- 医疗保健专业人员经常使用食品和药物管理局 (FDA) 监管的药物和医疗设备.
- 了解FDA的批准流程和解释临床试验数据对于有信息的患者护理至关重要.
- 现有的医学和药学课程建议对这些主题进行教育,但学生的知识尚未得到评估.
研究的目的:
- 评估最后一年的健康专业学生对FDA监管和临床研究证据的解释的知识.
- 确定未来医疗保健提供者对FDA批准要求和临床试验质量理解的差距.
主要方法:
- 开发了一项24项调查,以自我评估学生对FDA批准流程的接触,对证据要求的理解以及解释试验数据的能力.
- 这项调查对加利福尼亚大学旧金山分校的333名医学,药学和家庭护士课程的毕业生进行.
- 在2024年1月至4月期间收集了175名受访者 (53%的受访率) 的数据.
主要成果:
- 71%的受访者接受了关于FDA药物批准的教学,但90%的人将其描述为基本或肤浅的,而58%的人希望获得更多的教学.
- 只有14%的人报告了有关医疗器械批准的教学.
- 尽管38%的人认为他们对FDA药物批准的理解中等到优秀,但只有3%的人正确确定了批准标准,17%的人承认全因死亡终点的优越性.
结论:
- 医疗专业学生对FDA批准过程和新医疗产品的证据质量表现出有限的理解.
- 显然需要加强有关监管科学和临床试验解释的教育课程.
- 改善教育将使未来的临床医生更好地做出基于证据的决策,并与患者有效地沟通医疗产品.
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