癌症临床试验第一阶段的变化趋势
Richard Kelly1,2,3, Christina Guo4, Jayesh Desai1
1Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.
Contemporary clinical trials communications
|January 11, 2024
概括
瘤药物开发正在转向早期阶段 (Ph1) 临床试验中的免疫疗法和组合疗法. 趋势显示免疫疗法研究的增加和化疗的减少,随着地理分布的演变.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 药物开发 药物开发
背景情况:
- 早期阶段 (Ph1) 瘤学试验的景观是动态的,受癌症生物学见解和新的治疗方法的影响.
- 了解Ph1试验设计的趋势对于预测未来的癌症治疗发展至关重要.
研究的目的:
- 分析2009年至2021年期间进行的固体瘤Ph1瘤学试验的趋势.
- 识别治疗类,组合策略,瘤类型和地理分布的变化.
主要方法:
- 从2009年到2021年在clinicaltrials.gov上注册的7061个固体瘤Ph1试验的综合分析.
- 评估试验开始的数量,治疗类,组合类型,瘤焦点和地理分布.
主要成果:
- Ph1瘤学试验每年增长5.2%,免疫疗法显著增加,化疗试验下降.
- 多剂组合试验超过单剂试验;单类试验数量超过多式组合.
- 亚太地区的试验比例增加,而COVID-19大流行暂时将试验转向单一地区的北美研究.
结论:
- 早期瘤学药物开发阶段显示出明确的转向免疫疗法和组合疗法.
- 地理分布和试验行为受到COVID-19大流行影响,需要进行大流行后监测.
- 新兴的模式,如抗体药物合物 (ADC) 和细胞疗法,需要持续监测.
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