(Total Views: 717)
Posted On: 09/23/2020 2:29:06 PM
Post# of 154977
Great - glad we are on the same page - maybe different emphasis.
My focus was on distinguishing two events: (1) trial stoppage by DSMC for efficacy, and (2) releasing full data upon DSMC saying "will be significant if trends continue."
We agree on (1) and how that plays to required final p. Still not sure we look at (2) - which is what NP responded to - in the same way. The value of information depends on what actions you can take based on it.
If the endpoint isn't altered, maybe the number of patients would be? In considering that, knowing whether our relative improvement isn't what we expect or whether there were simply too few "events" might be relevant.
A caveat: I heard NP say the data could be released to CytoDyn. I'm not sure I heard him say the data could be released to the public. I hope the FDA wouldn't object to interim results being used to help recruit study patients.
My focus was on distinguishing two events: (1) trial stoppage by DSMC for efficacy, and (2) releasing full data upon DSMC saying "will be significant if trends continue."
We agree on (1) and how that plays to required final p. Still not sure we look at (2) - which is what NP responded to - in the same way. The value of information depends on what actions you can take based on it.
If the endpoint isn't altered, maybe the number of patients would be? In considering that, knowing whether our relative improvement isn't what we expect or whether there were simply too few "events" might be relevant.
A caveat: I heard NP say the data could be released to CytoDyn. I'm not sure I heard him say the data could be released to the public. I hope the FDA wouldn't object to interim results being used to help recruit study patients.
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