Pfizer Global Research, Groton, Connecticut, USA.
Bakar Computational Health Sciences Institute, University of California, San Francisco, San Francisco, California, USA.
Clin Transl Sci. 2020 Jul;13(4):665-674. doi: 10.1111/cts.12756. Epub 2020 Mar 10.
Efforts for sharing individual clinical data are gaining momentum due to a heightened recognition that integrated data sets can catalyze biomedical discoveries and drug development. Among the benefits are the fact that data sharing can help generate and investigate new research hypothesis beyond those explored in the original study. Despite several accomplishments establishing public systems and guidance for data sharing in clinical trials, this practice is not the norm. Among the reasons are ethical challenges, such as privacy of individuals, data ownership, and control. This paper creates awareness of the potential benefits and challenges of sharing individual clinical data, how to overcome these challenges, and how as a clinical pharmacology community we can shape future directions in this field.
由于人们越来越认识到集成数据集可以促进生物医学发现和药物开发，因此分享个体临床数据的努力正在增强。其中的好处包括，数据共享可以帮助生成和研究原始研究中未探索过的新研究假设。尽管在临床试验中建立了一些公共系统和数据共享指导方针，但这一做法并不常见。其中的原因包括伦理挑战，例如个人隐私、数据所有权和控制权。本文旨在提高人们对分享个体临床数据的潜在益处和挑战的认识，探讨如何克服这些挑战，以及作为临床药理学界，我们如何塑造这一领域的未来方向。
