印度在临床试验登记处注册的多国性,干预性,第二期或第三期试验中的代表:印度:一个横截面研究
Jaishree Mendiratta1, Ravi N Vaswani2, Gayatri Saberwal1
1Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru, Karnataka, India.
PloS one
|September 20, 2023
概括
印度的跨国临床试验有时会过度招募本地参与者,特别是那些有外国赞助商的参与者. 这引发了对公平的负担分担和数据完整性的担忧,需要对印度临床试验注册局 (CTRI) 进行更好的监督.
科学领域:
- 临床试验 临床试验
- 公共卫生道德 公共卫生道德
- 监管科学 监管科学
背景情况:
- 在印度进行的跨国临床试验在参与者招募方面面临严格审查.
- 人们担心来自印度的不成比例的招聘,可能会给当地人口带来不公平的负担-收益比率.
研究的目的:
- 评估跨国干预第二阶段和第三阶段试验中从印度过度招募 (60%或更高) 的程度.
- 识别有问题的试验,印度的计划或实际招募很高,特别是那些有外国赞助商的试验.
主要方法:
- 从印度临床试验注册局 (CTRI) 下载和分析了2013-2020年期间的试验记录.
- 评估了已完成和未完成的2/3期干预研究中本地参与者的比例.
- 确定了有计划或实际招募60%或更多来自印度的试验,并评估了赞助商国籍.
主要成果:
- 完成的试验中有8%有60%或更多的计划从印度招募;其中7%有外国赞助商.
- 11%的完成试验中有60%或更多的实际从印度招募;10%有外国赞助商.
- 7%的未完成试验中有60%或更多的计划从印度招募;5%有外国赞助商,并且可能存在问题.
结论:
- 几项跨国试验显示印度有计划或实际的过度招聘,其中很大一部分涉及外国赞助商.
- 在已完成的研究中观察到CTRI中及时记录更新的问题.
- 建议包括提高监管警,以应对过度招聘,以及改善CTRI数据管理,用于跨国试验.
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