The case for unblinding He seemed that what he
Post# of 154722
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Posted On: 10/23/2020 6:54:49 PM
The case for unblinding
Which would seem to indicate unblinding before the DSMC recommendation. But that's not how it works. A company would always wait for the DSMC recommendation first and if the DSMC doesn't recommend submitting the company can decide to abide by the DSMC recommendation or not.
Since a halt was not recommended the trial could have continued, the results could have been unblinded and submitted and only the small statistical penalty would have applied. Even now they could continue the trial, unblind and submit.
The positives of unblinding and submitting far outweigh the small negative of a statistical penalty,
negative: small statistical penalty and the trial continues on.
positives: Tens of thousands of lives saved if approved now.
We won't face an increasing SOC that could wipe out the statistical significance.
Potentially first to approval in severe/critical so we're not comparative to other drugs with a later EUA submission.
First to market with revenue to pay the bills and advance other trials.
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He seemed that what he was saying is that if we take the penalty, we lose the option to increase the size of the trial to offset.
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In case we needed to increase the size of the trial and had taken the statistical penalty then we wouldn't be able to do that and that would potentially harm us. So when the DSMC came back and said continue the enrollment to achieve your primary endpoint and in 62 more patients come and let us look at the data again.
Which would seem to indicate unblinding before the DSMC recommendation. But that's not how it works. A company would always wait for the DSMC recommendation first and if the DSMC doesn't recommend submitting the company can decide to abide by the DSMC recommendation or not.
Since a halt was not recommended the trial could have continued, the results could have been unblinded and submitted and only the small statistical penalty would have applied. Even now they could continue the trial, unblind and submit.
The positives of unblinding and submitting far outweigh the small negative of a statistical penalty,
negative: small statistical penalty and the trial continues on.
positives: Tens of thousands of lives saved if approved now.
We won't face an increasing SOC that could wipe out the statistical significance.
Potentially first to approval in severe/critical so we're not comparative to other drugs with a later EUA submission.
First to market with revenue to pay the bills and advance other trials.
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