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Doc logic

09/24/16 7:36 PM

#76128 RE: learningcurve2020 #76119

learningcurve2020,

FDA will almost never peek until there is no more plausible explanation. The DMC may have recommended a halt but until a median can be established for actual benefit, the company has a right to keep everything continuing to insure best benefit outcome. FDA can change things up, though, if they have reason to believe some group is being placed in a less advantaged situation and median will be reached without adding any more to this group than necessary to preserve the integrity of the trial. Best wishes.
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HappyLibrarian

09/24/16 11:24 PM

#76150 RE: learningcurve2020 #76119

Trial integrity would not be impacted by saying it is near completion, therefore the reason they aren't saying it is because it isn't so.