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在儿童中进行的临床试验
Patrina H Y Caldwell1, Sharon B Murphy, Phyllis N Butow
1Centre for Kidney Research, The Children's Hospital at Westmead, New South Wales, Australia. Patrinac@chw.edu.au
Lancet (London, England)
|September 1, 2004
概括
儿科临床试验对儿童健康至关重要,但也面临着挑战. 应对这些挑战至关重要,以确保儿童平等地从医学进步中受益.
科学领域:
- 生物医学科学 生物医学科学
- 翻译研究是翻译研究.
- 儿科健康 儿科健康
背景情况:
- 许多儿科治疗方法缺乏足够的测试,导致潜在的伤害或保留好处.
- 由于疾病负担和财务因素,研究重点往往集中在成年人身上,忽视了临床试验中儿童的权利.
- 越来越多的人认识到对儿科试验的需要,这正推动全球立法变革.
研究的目的:
- 探索与对儿童进行随机试验相关的挑战.
- 确定改善儿科临床试验参与和进行的策略.
- 倡导儿童在医学研究中的公平参与.
主要方法:
- 对儿科临床试验现有文献的综述.
- 对影响儿童参与试验的因素的分析.
- 探索儿科研究中的伦理考虑.同意.
主要成果:
- 儿科试验更复杂,因为患者池较小,同意门更高.
- 家长和儿科医生的犹影响了试验招生,经常偏爱标准护理或新的干预措施而不是参与试验.
- 尽管存在挑战,但立法任务正在增加对儿科药物检测的要求.
结论:
- 改善儿科试验的进行需要解决招聘和同意的复杂性.
- 确保儿童从生物医学进步中受益,需要专门的研究和克服参与障碍.
- 公平地参与临床试验是儿童的基本权利.
关键词:
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