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开放临床试验数据:自愿数据共享门户是否足够?

Opening clinical trial data: are the voluntary data-sharing portals enough?

作者信息

Geifman Nophar, Bollyky Jennifer, Bhattacharya Sanchita, Butte Atul J

机构信息

Institute for Computational Health Sciences, University of California San Francisco, Mission Hall, 550 16th Street, 4th Floor, San Francisco, CA, 94158-2549, USA.

Sean N. Parker Center for Allergy Research, Department of Pediatrics, Division of Allergy, Immunology & Rheumatology, Stanford University School of Medicine, Stanford, CA, USA.

出版信息

BMC Med. 2015 Nov 11;13:280. doi: 10.1186/s12916-015-0525-y.

Abstract

Data generated by the numerous clinical trials conducted annually worldwide have the potential to be extremely beneficial to the scientific and patient communities. This potential is well recognized and efforts are being made to encourage the release of raw patient-level data from these trials to the public. The issue of sharing clinical trial data has recently gained attention, with many agreeing that this type of data should be made available for research in a timely manner. The availability of clinical trial data is most important for study reproducibility, meta-analyses, and improvement of study design. There is much discussion in the community over key data sharing issues, including the risks this practice holds. However, one aspect that remains to be adequately addressed is that of the accessibility, quality, and usability of the data being shared. Herein, experiences with the two current major platforms used to store and disseminate clinical trial data are described, discussing the issues encountered and suggesting possible solutions.

摘要

全球每年开展的众多临床试验所产生的数据,有可能对科学界和患者群体极为有益。这种潜力已得到充分认可,人们正在努力鼓励将这些试验中的原始患者层面数据向公众发布。临床试验数据共享问题最近受到关注,许多人一致认为这类数据应及时提供用于研究。临床试验数据的可获取性对于研究的可重复性、荟萃分析以及研究设计的改进最为重要。该领域围绕关键数据共享问题展开了大量讨论,包括这种做法存在的风险。然而,一个仍有待充分解决的方面是所共享数据的可访问性、质量和可用性。本文描述了目前用于存储和传播临床试验数据的两个主要平台的使用经验,讨论了遇到的问题并提出了可能的解决方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac9f/4642633/d1dff69eeef4/12916_2015_525_Fig1_HTML.jpg

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