癌症缓解症临床试验中的生物标志物终点:缓解症终点系列系统综述5
Michael S Yule1,2, Joshua Thompson3, Khachonphat Leesahatsawat3
1St Columba's Hospice, Edinburgh, UK.
Journal of cachexia, sarcopenia and muscle
|May 24, 2024
概括
这项系统性审查发现,虽然生物标志物在癌症缓解症试验中经常被测量,但它们通常被用作探索性而不是主要终点. 澄清生物标志物变化与临床益处之间的联系对于监管药物批准至关重要.
科学领域:
- 在瘤学瘤学.
- 翻译医学是一种翻译医学.
- 生物标志物研究 生物标志物研究
背景情况:
- 监管机构要求药物批准时与临床益处相关的验证终点.
- 生物标志物经常在癌症缓解症试验中测量,通常作为代用终点.
- 生物标志物的实用性和应用在癌症缓解症研究中需要进行系统的评估.
结论:
- 生物标志物主要作为探索性而不是主要的终点用于癌症缓解症试验.
- 像白蛋白这样的常见生物标志物对营养干预缺乏反应性,这突显了基于机制的生物标志物选择的必要性.
- 建立生物标志物变化与临床益处之间的明确相关性对于它们作为监管批准的替代终点的接受至关重要.
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