在癌症临床试验中采用分散的试验元素,支持COVID-19期间的FDA批准
Timil H Patel1, Amy Corneli2,3, Pamela Balcazar4
1Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
概括
在COVID-19大流行期间,分散的临床试验 (DCT) 元素被广泛采用用于癌症试验,这证明了产生FDA批准的数据和改善患者访问的有效性.
科学领域:
- 在瘤学瘤学.
- 临床试验管理 临床试验管理
- 医疗信息学 医疗信息学
背景情况:
- 随着COVID-19的流行,传统的癌症临床试验受到严重影响.
- 实施了分散的临床试验 (DCT) 元素,以确保患者安全和试验的连续性.
研究的目的:
- 评估DCT元素在癌症临床试验中的采用和影响,从而在大流行期间获得FDA批准.
- 确定关于DCT实施的挑战和未来意图.
主要方法:
- 临床试验转型倡议 (CTTI) 向试验赞助商分发了一份调查.
- 收集了关于使用的DCT元素,实施挑战和未来使用的数据.
- 分析了来自13个赞助商的19份关于52项符合条件的试验的回复.
主要成果:
- 几乎所有赞助商 (95%) 在疫情期间采用了至少一个DCT元素.
- 通常使用的DCT元素包括远程现场监控 (89%),远程医疗 (68%) 和远程实验室评估 (63%).
- 主要挑战涉及机构政策 (83%),技术采用 (61%) 和监管限制 (56%).
结论:
- 在癌症临床试验中,DCT元素可用于生成FDA批准的数据.
- 赞助商打算继续使用DCT,特别是用于远程监控和远程医疗.
- 解决现场层面的挑战对于在瘤学研究中持续采用DCT至关重要.
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