支持药物批准的临床研究报告的可访问性:一个横截面评估
Ashley M Hopkins1, Natansh D Modi1, Frank W Rockhold2
1College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
Journal of clinical epidemiology
|January 14, 2024
概括
支持药物批准的临床研究报告 (CSR) 可用于69%的试验. 然而,只有22%可以直接下载,大多数需要赞助商请求这些关键的研究文件.
科学领域:
- 制药科学 制药科学
- 临床研究 临床研究
- 监管科学 监管科学
背景情况:
- 临床研究报告 (CSR) 对药物批准和监管审查至关重要.
- 由于EMA,加拿大卫生部和FDA等机构的授权,公众对CSR的访问量增加了.
- 了解企业社会责任的可访问性对于独立的研究和药物安全评估至关重要.
研究的目的:
- 量化支持公开可下载的批准药物的国家药物建议的比例.
- 确定国家建议书的比例,可由独立研究人员向研究赞助商提出.
- 评估销量最高的药品国家级建议书的整体可访问性.
主要方法:
- 一项横截面研究分析了与2021年FDA批准的前30种收入最高的药物相关的行业赞助试验的CSR.
- 通过公共存储库 (EMA,加拿大卫生部) 和赞助数据共享政策来评估企业社会责任的可用性.
- 独立研究人员申请的试验资格根据赞助商政策确定.
主要成果:
- 研究了来自316项临床试验的CSR;22% (70) 是公开下载的,其中37个在EMA和40个在加拿大卫生部.
- 58% (183) 的试验的CSR符合赞助商要求的资格.
- 总体而言,69% (218) 的试验具有可下载或符合赞助商要求的CSR.
结论:
- 大多数支持药物批准的临床试验 (69%) 有可访问的CSR.
- 从监管机构直接向公众下载国家级建议书的数量仅为22%.
- 其余可访问的CSR需要向研究赞助商提出正式请求,突出了立即访问的障碍.
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