印度的癌症试验生态系统 - 准备好首播时间吗?
Arun K Mankan1, Abhishek Shankar2, Sewanti Limaye3
1Fortrea Inc, Durham, NC.
JCO global oncology
|June 13, 2024
概括
印度为全球瘤学临床试验提供了优势,包括大量患者和成本效益. 最近的监管改进增强了它的吸引力,尽管在不断变化的临床试验环境中存在过去的挑战.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 监管科学 监管科学
背景情况:
- 全球癌症临床试验是复杂的,漫长的,昂贵的.
- 选择地点的关键考虑因素包括患者人口统计学,研究者专业知识,基础设施和经济可行性.
- 印度历来为国际临床研究提供了机遇和挑战.
研究的目的:
- 审查印度临床试验的不断变化的格局.
- 突出目前瘤学试验的监管环境.
- 讨论在印度进行全球瘤临床试验的优势和挑战.
主要方法:
- 印度临床试验环境的回顾.
- 对监管框架的分析,包括2019年新药和临床试验规则.
- 讨论影响瘤学研究地点选择的因素.
主要成果:
- 印度拥有庞大,多样化且对治疗毫不了解的患者群体.
- 城市地区的成本效益和优质医疗保健基础设施是显著的优势.
- 监管环境在2019年规则之后稳定,解决了以前的担忧.
结论:
- 印度是全球瘤学临床试验的有吸引力的地点,因为它的患者池,成本和改善的监管框架.
- 赞助商必须权衡好处与潜在挑战,包括需要持续监管监测.
- 该国训练有素的劳动力和医疗保健设施支持复杂的试验执行.
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