Post-unblinding changes to a statistical analysis plan doom even highly promising therapeutic signals.
Even when peer-reviewed publications validate clinical efficacy, regulatory agencies will reject a drug candidate if the sponsor altered the statistical analysis plan after unblinding.
The same conclusion keeps arriving from across the workspace's research — 1 topics independently instantiate this theme. Filter the evidence by where it came from:
Capricor's regulatory campaign faltered as the advisory committee rejected efficacy data tied to post-hoc, post-unblinding statistical modifications.
Changing the statistical analysis parameters post-unblinding to salvage an efficacy signal led the FDA to reject the trial as failed under its original plan.
The finding shows that reversing a post-unblinding statistical model correction caused the trial's key efficacy endpoints to lose statistical significance.
Disputes over post-unblinding modifications to the statistical analysis plan led to an advisory committee rejection of the therapy's efficacy.
The advisory committee rejected the drug due to suspicious late changes to the statistical analysis plan, even as a peer-reviewed publication validated the results under that modified plan.
The advisory committee rejected Capricor's cell therapy because the sponsor altered the statistical analysis plan post-unblinding, casting doubt on its clinical efficacy.
The advisory committee voted against the drug's approval because of structural disputes and post-hoc changes to its pre-specified statistical analysis plan.
The FDA rejected Capricor's efficacy claims because the sponsor made post-hoc modifications to its statistical analysis plan after the trial was unblinded.