Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

Chronic, I would not get too excited over reported or not reported duration of SOM. Mean and median durations happen to be the most frivolous measures used in SOM trials.

1. For unfathomable reasons SOM trials have adopted the way median and mean are calculated in survival trials and calculate both measures over the whole ITT population. When over half of the population does never get the ailment this way of calculating tends to give medians of 0 days and means of 1.5 days (as GALERA reported before dropping it as if it never happened) i.e. not very informative numbers. GALERA reporting 1.5 day mean was especially galling when the shortest observable duration of SOM in their trial was about half a week (subjects observed twice a week).

2. Also, from patient point of view there is major difference between 4 straight weeks (28 days) with SOM and four week period consisting 1 week of SOM, 2 weeks without SOM and, finally 1 week with SOM. Currently both get reported as 4 weeks of SOM.

I would prefer to see the duration expressed in actual days or weeks suffered from the ailment and only for subjects who got SOM. Then the combination of incidence rate and median or mean duration would tell us something useful.