儿童健康试验的设计,进行和报告的发展
Ami Baba1, Alex Aregbesola2,3, Patrina H Y Caldwell4
1Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
Pediatrics
|June 4, 2024
概括
儿科临床试验方法的进展缓慢,尽管儿童健康研究标准 (StaR) 的努力. 像患者参与和适应性设计这样的新兴趋势为儿童健康研究提供了未来的改进.
科学领域:
- 儿科临床试验儿童临床试验
- 儿童健康研究方法 儿童健康研究方法
背景情况:
- 儿童健康网络的研究标准 (StaR) 在2012年发布了初步标准,以改善儿科临床试验.
- 对247篇出版物的审查强调了在儿童健康研究中增加价值和减少浪费的研究实践.
研究的目的:
- 评估儿童临床试验方法关键领域的进展情况.
- 确定新兴趋势,以提高儿科试验的临床实用性.
主要方法:
- 来自StaR儿童健康作者出版物的评论.
- 评估包括同意,偏见,数据监测,样本大小,结果和年龄组在内的领域的进展.
- 探索新兴趋势和实施科学方法.
主要成果:
- 有意义的变化已经发生,但儿科试验方法的可测量的进展仍然很慢.
- 评估的主要领域包括同意,偏见,数据监测,样本大小,结果和年龄组.
结论:
- 新兴趋势,如患者参与,贝叶斯统计,自适应设计和平台试验等,可以促进儿科研究.
- 实施科学为改善儿童健康研究的设计,进行和报告提供了一个框架.
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