在印度的临床试验注册表中,赞助商的分类需要标准化
Jaishree Mendiratta1, Mounika Pillamarapu1, Gayatri Saberwal1
1Institute of Bioinformatics and Applied Biotechnology (IBAB), Bangalore, Karnataka, INDIA.
Indian journal of medical ethics
|February 20, 2024
概括
印度的临床试验注册数据存在缺失赞助商,不一致的分类和过度使用"其他"的问题. 改善印度临床试验注册表中的赞助商数据对于更好的透明度和自动化分析至关重要.
科学领域:
- 临床研究 临床研究
- 数据科学数据科学数据科学
- 公共卫生 公共卫生
背景情况:
- 在全球范围内,越来越重视临床试验注册.
- 在公共临床试验注册表中发现数据质量问题.
- 需要对注册表中的赞助商信息进行系统评估.
研究的目的:
- 在印度注册的干预试验的主要赞助商的分类.
- 识别和分析印度临床试验注册局 (CTRI) 赞助商数据中的问题.
- 为改善临床试验注册系统提供证据.
主要方法:
- 横截面研究设计. 截面研究设计.
- 从CTRI记录中提取2期,2/3期和3期试验 (2016年5月至2021年5月) 的数据.
- 应用过器来识别相关的试验和赞助商,然后进行分类.
主要成果:
- 对5,453项试验的分析揭示了赞助商识别和分类方面的问题.
- 赞助商数据问题包括缺少赞助商,不一致的分类,以及过度使用"其他"类别 (7.9%).
- 只有92.1%的赞助商被分为预定义的类别,突出显示数据质量差距.
结论:
- 该研究强调了CTRI中赞助商数据的重大缺陷.
- 暗示了改善数据准确性和一致性的建议.
- 需要对试验注册系统进行改进,以提高数据透明度和自动化分析.
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