(Total Views: 1021)
Posted On: 05/04/2017 4:06:58 PM
Post# of 72447
You are onto something Mr. Gamecock. Some will tell you that interim analysis is standard practice. True, but it's usually for the whole treatment period. For example, B-OM's interim contains results after 11 weeks, not 5.5 weeks.
P's interim will be after 6 weeks, but the total treatment period is 12 weeks + 4 weeks observation. That's unusual because sponsors know the FDA won't stop the trial early even if the results are excellent. Psoriasis isn't a life-threatening condition like cancer. They also know that the results at midpoint doesn't guarantee the drug will or won't work at the end.
So someone else must want to take an early look at the results. Hmm who could it be?
P's interim will be after 6 weeks, but the total treatment period is 12 weeks + 4 weeks observation. That's unusual because sponsors know the FDA won't stop the trial early even if the results are excellent. Psoriasis isn't a life-threatening condition like cancer. They also know that the results at midpoint doesn't guarantee the drug will or won't work at the end.
So someone else must want to take an early look at the results. Hmm who could it be?
Quote:
I'm convinced the ph2 B trial was designed by a BP, with the help from Dr B.
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