失去了自己的平衡吗? 在突破性治疗时代的试验行为挑战
Jaleh Fallah1, Flora Mulkey1, Mallorie H Fiero1
1Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
概括
突破性的癌症疗法对临床试验进行具有独特的挑战,包括保持平衡. 这些问题影响了新疗法研究的设计和执行.
科学领域:
- 在瘤学瘤学.
- 临床试验设计 临床试验设计
- 监管科学 监管科学
背景情况:
- 瘤学领域突破性疗法的快速发展为临床试验设计和执行带来了新的挑战.
- 保持平衡,即对首选治疗的真正不确定性的状态,随着有前途的新药越来越困难.
研究的目的:
- 讨论临床试验行为的挑战.
- 探索突破性疗法对试验设计和设备的影响.
主要方法:
- 文献审查和专家讨论当前瘤学试验的挑战.
- 分析快速治疗进步对研究方案的影响.
主要成果:
- 突破性疗法使得在临床试验中建立和维持平衡变得复杂.
- 试验进行面临与患者招募,伦理考虑和监管途径相关的障碍.
结论:
- 调整试验设计和进行是必要的,以适应突破性的瘤治疗的时代.
- 解决失去平衡和其他挑战对于有效推进癌症研究至关重要.
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