The 12th Invest in ME Conference, Part 1
OverTheHills presents the first article in a series of three about the recent 12th Invest In ME international Conference (IIMEC12) in London.
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Latest on Access to Data from Industry-Sponsored Clinical Trials

Discussion in 'Other Health News and Research' started by MeSci, Dec 18, 2014.

  1. MeSci

    MeSci ME/CFS since 1995; activity level 6?

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    Data Sharing, Year 1 — Access to Data from Industry-Sponsored Clinical Trials

    There has been considerable interest of late in increasing the transparency of clinical trials, including increasing access to the raw data from trials sponsored by the pharmaceutical industry.1 Since May 2013, investigators have been able to request access to deidentified patient-level data from clinical trials sponsored by GlaxoSmithKline,2 subject to review and oversight by an independent review panel (https://clinicalstudydatarequest.com/Default.aspx). As the members of this panel, we now have more than 12 months of experience with this initiative — and can report that it has been a productive and successful first step.

    The system was launched on May 7, 2013, and initially included approximately 200 clinical trials that had been started since January 1, 2007 — the date on which more consistent data standards began to be required for GlaxoSmithKline-sponsored trials. Additional studies were to be added to the system over time or by request. Data were to be requested through a publicly available website and were to include the raw data set, the analysis-ready data set, and the clinical study documents, but no original radiographs, electrocardiograms, or other images or test results, except by special request. Analyses were to be conducted by the investigators with the use of statistical software provided on a separate secure website, so that the data were not downloaded onto other computers. Investigators were responsible for obtaining any approvals required for their research (e.g., from institutional review boards). They were also required to sign a data-sharing agreement committing them to using the data only for the research purpose described in the accepted research proposal. Investigators were expected to disclose any conflicts of interest and to provide their plans for publishing the analyses in the medical literature. Approved applications are made public on the website.

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