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Thursday, January 30, 2020 2:39:08 PM
for the trial's secondary outcome to statistically fail, in which the treated arm shows less than a 2-month increase in OS, the results from blinded trial confirms that for this to occur, the SOC arm would outperform survivability of every other SOC trial arm performed in the past by numerous months, needing a whopping 19-month median OS. Though this would be considered a trial failure, due to the trial crossover design, this would easily be argued as a huge success, particularly with new draft guidance from the FDA leaning towards the use of historic controls, and for the fact that the vaccine itself has shown no negative effects on any patients. I find that with the analysis of the blinded data, it is extremely difficult, if not impossible to theorize what type of result would lead to a total trial failure, while still being true to the blinded data provided.
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