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Biotech / Medical : Cell Therapeutics (CTIC) -- Ignore unavailable to you. Want to Upgrade?


To: quidditch who wrote (450)2/23/2005 9:30:15 PM
From: Biomaven  Read Replies (1) | Respond to of 946
 
It's basically a comparison of survival - not much room for argument on survival itself, but the statistical test for comparing two survival curves is always hard to grasp. (How do you compare a curve where everyone lives a medium time to one in which some die quickly but some live a very long time, for instance?)

They are trying to show statistical superiority of Xyotax plus carboplatin to Taxol plus carboplatin. It's always hard to show statistical superiority over an approved drug, but I guess they went this route because the alternative of a non-inferiority trial had problems as well because in this patient population there was considerable uncertainty about how well the comparator does.

The trial had to proceed until the desired number of "events" - euphemism for deaths - had occurred. This took much longer than projected. This means that either these patients were somehow different than other historical patients with their same characteristics (not impossible as these trials are mostly taking place outside the US) or Xyotax is working very well.

Peter