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

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• 作者：Nophar Geifman ; Jennifer Bollyky ; Sanchita Bhattacharya ; Atul J. Butte
• 关键词：Clinical data ; Clinical trials ; Meta ; analysis ; Open access ; Reanalysis
• 刊名：BMC Medicine
• 出版年：2015
• 出版时间：December 2015
• 年：2015
• 卷：13
• 期：1
• 全文大小：600 KB
• 刊物主题：Medicine/Public Health, general; Biomedicine general;
• 出版者：BioMed Central
• ISSN：1741-7015

文摘

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.