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Monday, June 01, 2020 6:09:51 PM
I saw your post and agree totally
I don't believe we are right at 10%, it would be too big coincidence with a number that was not set from clinical results but as a minimum threshold to be triggered by a sample size of 298 events, and probably a number which, if reached, would satisfy the FDA that the cure can be used as a standard of care because it shows enough benefit. Those 10% have no "clinical" justification, it is just a reasonable "acceptation threshold" that can be highlighted by a reasonable sample size (not too big to avoid too costly trial).
Therefore, if efficient, the drug must have been proven so (through significance analysis) in the last IDMC meeting, because it is likely more efficient than those 10% and did not need the whole sample (298) to reach enough power.
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