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7 Clinical Trial and Research Data
Pages 45-50

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From page 45...
... . • To share clinical trial data for future analyses, data need to be curated and formatted in a standardized manner, such as using Clinical Data Interchange Standards Consortium (CDISC)
From page 46...
... Funders certainly want to see data sharing to improve transparency and reproducibility of the primary analyses, she said, while other stakeholders may be more interested in building a common resource for many people to use. Harmonizing research data from the AMP and other non-clinical research projects present additional challenges, said Mangravite.
From page 47...
... She added that clinical trials should plan for data sharing up front and for the reuse of data by understanding better what similar trials are being conducted and leveraging data that have already been collected. CURRENT PROMISING PRACTICES IN CLINICAL TRIAL AND RESEARCH DATA SHARING Li described Vivli, a nonprofit, global, data-sharing platform built on the Microsoft Azure cloud.
From page 48...
... She suggested that in the future there may be machine-learning approaches that will enable standardization of such data. ISSUES TO BE RESOLVED FOR SHARING CLINICAL TRIAL AND RESEARCH DATA When executing good, large, prospective trials, investigators have a duty to curate those data for future analyses, according to Lisa Merck.
From page 49...
... Harmonizing and sharing preclinical data represents another and possibly more difficult challenge because preclinical research is even more siloed than clinical research, said Hicks. However, she said that One Mind tried to do this in the traumatic brain injury field by identifying some common data elements.


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