中国循证医学杂志

中国循证医学杂志

促进临床试验数据共享,提高临床试验的透明化

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临床试验数据共享可以增加临床试验的透明度,提高临床试验的真实性。现有的临床试验数据透明化要求并不完善,要达到临床试验数据共享常态化,目前尚面临着众多困难。本文分析了临床试验数据共享工作存在的各种困难,并在数据所有权、技术、操作和法律层面等多个方面系统性地提出了解决思路,倡议与呼吁临床试验数据共享,以期能促进临床试验透明化工作的推进,最大限度地降低临床试验风险,使数据共享发挥最大的效益。

Sharing clinical trial data can increase the transparency of clinical trials, improve the authenticity of clinical trials. The current clinical research data transparency requirements are not satisfied, and it is still difficult to create an environment in which the sharing of deidentified data becomes the norm. The article has analyzed various concerns voiced about data sharing and proposed solutions in data ownership, technology, implementation, and legal issues systematically, calling for clinical trial data sharing in order to promote transparency of clinical trials, looking forward to minimizing the risks and maximizing the benefits of data sharing.

关键词: 临床试验; 数据共享; 透明化; 临床试验真实性

Key words: Clinical trial; Data sharing; Transparency; Authenticity of clinical trial

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