(Total Views: 654)
Posted On: 05/19/2020 10:06:17 AM
Post# of 153903
Re: Rubraquercus #34598
Rubraquercus,
Yup, DSMB could arguably intervene. But my feeling here is that:
1) The trial is very short
2) The drug is safe (need less monitoring regarding safety, if at all).
3) This is a P2 trial with 75 patients only and the objective is to demonstrate benefit, therefore would be good to let it finalize un-tampered.
Actually, I think un-blinding the data before full enrollment is a mistake. We can wait a couple of weeks to give us good-powered results.
The question in my mind is what will happen when the resultant p-value is shown to be very low.
Will the FDA request a P3 trial with 100's of patients ??
Will the FDA say: in light of the urgency and extraordinary proof of benefit this is good enough. We will approve for use with "P4" follow up?
This is the question ...
Yup, DSMB could arguably intervene. But my feeling here is that:
1) The trial is very short
2) The drug is safe (need less monitoring regarding safety, if at all).
3) This is a P2 trial with 75 patients only and the objective is to demonstrate benefit, therefore would be good to let it finalize un-tampered.
Actually, I think un-blinding the data before full enrollment is a mistake. We can wait a couple of weeks to give us good-powered results.
The question in my mind is what will happen when the resultant p-value is shown to be very low.
Will the FDA request a P3 trial with 100's of patients ??
Will the FDA say: in light of the urgency and extraordinary proof of benefit this is good enough. We will approve for use with "P4" follow up?
This is the question ...
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