Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, USA.
Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, USA.
Trends Cancer. 2021 May;7(5):395-399. doi: 10.1016/j.trecan.2020.12.009. Epub 2021 Jan 9.
Despite both enthusiasm and concern regarding data sharing from clinical trials, few studies have documented the outputs of data sharing. The FDA has a considerable collection of raw data from drugs for their marketing authorization. An examination of data sharing with the FDA provides a snapshot into studies that this may facilitate.
尽管人们对临床试验的数据共享既充满热情又有所担忧,但很少有研究记录数据共享的成果。FDA 从其药品上市许可的申请中收集了大量原始数据。对与 FDA 共享数据的研究进行考察,可以了解到这可能带来的便利。