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临床试验参与者对数据共享风险和益处的看法
Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing


Michelle M. Mello ... 其他 • 2018.06.07
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• 数据共享的重要性和复杂性 • 癌症临床和基因组数据共享——需要全球性解决方案 • 向癌症基因组数据的共享愿景进发 • 处于十字路口的数据共享

摘要


背景

共享参与者水平的临床试验数据具有潜在益处,但因为担心对参与者有潜在危害,一些药物开发的申办者和研究者敦促谨慎行事。关于临床试验参与者对数据共享风险的看法,我们知之甚少。

 

方法

我们对美国三家学术医疗中心多项临床试验的771例当前和近期参与者进行了一项结构化调查。我们通过邮件(350例完成了调查)以及在诊所候诊室(421例完成了调查)分发了调查问卷(总回复率,79%)。

 

结果

不到8%的回复者认为数据共享的潜在负面影响超过获益。总共93%的回复者很可能或比较可能会将自己的数据与大学科学家共享,82%的回复者很可能或比较可能与营利性公司的科学家共享。除了愿意共享数据用于诉讼的参与者较少之外,在不同的数据使用目的之间,共享数据的意愿没有明显变化。回复者最担心的问题是数据共享可能会使其他人不太愿意参与临床试验(37%很担心或比较担心),数据将用于营销目的(34%),或者数据可能被盗(30%)。对歧视(22%)和利用数据获利(20%)的担心较少。

 

结论

在我们的研究中,很少有临床试验参与者对数据共享的风险有强烈的担心。只要有充分的安全保护措施,大多数参与者愿意共享他们的数据用于广泛的用途(由Greenwall Foundation资助)。





作者信息

Michelle M. Mello, J.D., Ph.D., Van Lieou, B.S., and Steven N. Goodman, M.D., Ph.D.
From the Department of Health Research and Policy, Stanford University School of Medicine (M.M.M., V.L., S.N.G.) and Stanford Law School (M.M.M.) — both in Stanford, CA. Address reprint requests to Dr. Mello at Stanford Law School, 559 Nathan Abbott Way, Stanford, CA 94305, or at mmello@law.stanford.edu.

 

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