印度首次在人体试验中相差的要求:小组讨论小组的程序
Nusrat Shafiq1, Soumya Vij2, Arun Kumar Pradhan3
1Department of Pharmacology, Clinical Pharmacology Unit, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Clinical pharmacology and therapeutics
|February 12, 2026
概括
印度正在加强其临床研究能力,但对参与者安全和伦理方面的担忧阻碍了对外部产品的早期药物试验. 一个小组评估了在印度首次在人身上 (FIH) 研究的前景.
科学领域:
- 临床研究临床研究
- 药物开发 药物开发
- 监管科学是一种监管科学.
背景情况:
- 印度已经改善了临床研究基础设施和药物开发的法规.
- 从历史上看,对参与者安全,伦理和研究能力的担忧限制了非印度开发产品的首次人体 (FIH) 研究.
- 解决这些问题对于扩大全球早期临床试验机会至关重要.
研究的目的:
- 检查在印度进行FIH试验的监管,道德,基础设施和创新者观点.
- 确定在印度以外开发的产品启动FIH研究的障碍和促进者.
- 为加强印度在全球早期药物开发中的地位制定战略提供信息.
主要方法:
- 召开了多方利益相关者小组,包括监管机构,学术界,工业界和资助机构的代表.
- 对现有的监管框架和道德准则进行了全面审查.
- 分析了FIH试验的基础设施准备和创新者要求.
主要成果:
- 该小组确定了改善监管清晰度,道德监督和研究能力的关键领域.
- 特别强调了与数据完整性,知识产权和参与者的长期安全相关的具体问题.
- 基础设施评估表明需要加强专业设施和训练有素的人员.
结论:
- 印度拥有对外部产品进行FIH试验的潜力,这取决于解决已确定的监管,伦理和基础设施挑战.
- 利益相关者之间的协作努力对于建立信任和确保参与者的安全至关重要.
- 成功实施FIH研究可以显著提高印度在全球制药创新的作用.
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