对于收入最高的药物,个人参与者共享数据的状态
Natansh D Modi1, Lee X Li1, Jessica M Logan2
1College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.
大多数销量最高的药物的临床试验有资格共享数据,但正在进行的试验和公司内部流程阻碍了访问. 改进数据共享需要开放访问模型和独立平台.
科学领域:
- 临床试验的管理管理.
- 制药行业 制药行业 制药行业
- 数据共享政策数据共享政策
背景情况:
- 利益相关方对个人参与者数据 (IPD) 分享的压力越来越大.
- 审计显示IPD共享有限,特别是对于高收入药物.
- 需要评估IPD共享对支持最销药物的试验的资格.
研究的目的:
- 评估IPD对2021年收入最高的前30种药物的临床试验的共享资格.
- 确定影响试验数据共享的因素.
- 评估当前的数据共享实践和平台.
主要方法:
- 316项临床试验的横截面分析.
- 定义的资格作为数据平台上的公开上市或赞助商确认.
- 从临床试验.gov,欧盟临床试验登记册和PubMed.gov收集的数据.
- 检查了试验阶段,完成日期和数据共享管理.
主要成果:
- 201个 (64%) 的试验确认符合IPD共享的条件.
- 102个 (32%) 的试验证实不符合条件.
- 与独立平台 (例如Vivli) 观察到更高的共享率.
- 目前正在进行的试验显示,IPD共享资格明显较低.
结论:
- 对最高收入的药物进行的大量试验有资格获得IPD共享.
- 对于正在进行的试验和内部管理的共享流程,仍然存在挑战.
- 采用开放访问模型和独立平台可以提高数据共享率.
- 需要标准化政策,以便在药物获得批准后立即提供IPD.
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