George, the hem/trauma (same disorder target by ICOS = debacle)trial
is designed to look for decrease in the composite ARDS/Pneumonia.
Your previous ARDS post is very interesting, they found to etiologies clearly defined by time:
1.EARLY due to hem/trauma itself, and not theoretically possible to be changed by Bpi.
2.LATE due to pneumonia, both are then theoretically (and in the practice it happened in phase II trial post hoc) preventable by bpi.
...a refreshment:
Message 9448765
Then a hem/trauma trial focus to prevent ARDS/pneumonia (A/p) composite:
p less than 0.05
Power 90% (already mentioned by xoma, notice that previous study was 400 patients total and Power 80%)
confidence level 95%
two tail test, alpha 0.5
Placebo N 412, A/p 30%
Bpi N 412, A/p 20%
Total Recrutiment of 824 !!!!!!
Notice that mortality is not the end point here!!! at least not the only one.
Interesting indeed that as per gw observation Xoma stop providing numbers after some 800 recruits, and Supro is so eager so early, plus the big following of this Supro (now we need Tokyo Joe burrito).
The trial will not be pivotal without decreasing mortality, but will help the data for NDA.
I would like to see 2,000 to 3,000 patients recruited and get all the answers now (meaning in one or two more years), but it seems some one wants fast err.
gw many times this trials are continue in open label fashion so the recruitment could be intact and ongoing, but the blind phase already halted in the database.
|
