结核病治疗随机对照试验中的临床终点估计:已完成试验中的追溯应用
Isabelle R Weir1, Suzanne M Dufault2, Patrick Pj Phillips2
1Harvard University T H Chan School of Public Health.
Research square
|November 21, 2023
概括
标准化结核病 (TB) 治疗试验结果使用ICH E9 (R1) 估计和框架至关重要. 我们的分析证实,新型结核病治疗方案与标准护理并非不逊色,无论使用的估计或估计方法如何.
科学领域:
- 临床试验方法论 临床试验方法论
- 传染病研究 传染病研究
- 监管科学 监管科学
背景情况:
- 结核病 (TB) 试验使用复合结果,导致定义的变化,阻碍了指导方针的发展.
- 国际协调委员会 (ICH) E9(R1) 附录为标准化结核病试验结果定义和分析提供了机会.
- 为结核病治疗试验提出了四个先前定义的估计值.
结论:
- 拟议的ICH E9(R1) 估计为结核病治疗试验提供了一个标准化的框架.
- 使用REMoxTB试验数据证明了实用性,在估计结果中显示了一致的结论.
- 建议在未来的晚期结核病试验中采用这些估计值,以提高严谨性和减少变异性.
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