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N of 1 Data Sharing: The Impact of Data Sharing within the Hematology–Oncology Drug Products Division of the US FDA
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https://doi.org/10.1016/j.trecan.2020.12.009Abstract
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.
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