青少年参与结核病临床试验的促进者和障碍
J M Mangan1, K N C Hedges1, M M Salerno2
1Division of Tuberculosis Elimination, Centers for Disease Control, Atlanta, GA.
概括
成功地将青少年纳入结核病 (TB) 药物试验需要外部伙伴关系和灵活的方法. 解决监管障碍和改善研究规划是未来儿科结核病研究的关键.
科学领域:
- 临床试验 临床试验
- 儿科研究 儿科研究
- 结核病 (TB) 治疗方法
背景情况:
- 青少年参与结核病药物试验对于制定适合儿童的治疗方案至关重要.
- 结核病试验联盟研究31/艾滋病临床试验组A5349 (S31/A5349) 包括12岁及以上的青少年.
- 这项研究调查了青少年在临床试验中招募,入学和留学的促进者和障碍.
研究的目的:
- 确定使青少年参与结核病临床试验的因素和障碍.
- 收集与青少年入学有关的调查人员和协调员的见解.
- 为改善未来青少年参与临床研究的战略提供信息.
主要方法:
- 采访了注册和非注册网站的调查人员.
- 与注册和非注册网站的研究协调员举行了重点小组.
- 分析了转录的讨论,并与咨询小组验证了摘要.
主要成果:
- 促进者包括强大的外部合作伙伴关系,时间安排灵活性,投入的员工,多站点招聘,专注的现场员工,青少年友好的环境和有效的沟通.
- 监管问题是未注册网站的主要障碍.
- 建议侧重于加强研究规划和现场准备.
结论:
- 积极的伙伴关系和机构合作对于克服青少年参与结核病试验的障碍至关重要.
- 解决监管和后勤方面的挑战可以提高招聘和保留率.
- 这些发现为优化青少年参与儿科临床研究提供了一个框架.
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