steve1035

BioMS: Hype or Hope?

Thanks again Richard for the info. For the phase II trial this is what they used:
"Clinical progression was defined as a sustained (6 months) increase in EDSS scores of 1 unit if the baseline score was <5.5 or of 0.5 units if the baseline was 5.5 or higher"

BioMS: Hype or Hope?

Richard,
appreciate your valuable analysis. Do you have any opinion on how differences in EDSS scores between placebo and treatment groups might have affected the data in the phase II trial?
When you look at the average time a patient spends at each EDSS score you will find that a patient with a EDSS score from 3-5 will progress to the next level on average in 12-18 months. For an EDSS score from 6-8 the average time to progressing is about 32-48 months. In the very small phase II trial the placebo group had 3 patients with scores between 3-5, the rest were 6-8. In the treatment group there was only 1 patient with an EDSS score from 3-5, the rest were 6-8. So based on averages you would predict that in a 24 month study 3 out of 10 placebo group patients will probably show disease progression. (actual result was 6/10) where as only 1 out of the 10 in the treatment group would progress. (actual result 0/10)
So based on just the EDSS scores of the patients going into the study would you not have expected more patients in the placebo group to progress than patients in the treatment group? Thanks,

Steve