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Ann: Ethics Approval for Phase 2 Atopic Dermatitis Study Received, page-26

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  1. 183 Posts.
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    I assume that Matt and Bill - with all those FDA approved products on their record - know better than most about the FDA trial integrity requirements and that even though the current trials do not require Data Monitoring Committees (DMC), access to data by the sponsor during a trial under the current requirements by the FDA can actually invalidate the whole trial. Are Matt and Bill that irresponsible? I don't think so.
    If you're following the current discussion on possible 'leakages' on the trial, you may want to read the following and particularly lines 1046 to 1055:



    upload_2018-12-19_18-7-29.png
    upload_2018-12-19_18-9-44.png

    https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm201790.pdf

    https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm127073.pdf
    Last edited by vitruvius: 19/12/18
 
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