Replies to post #94251 on Avid Bioservices Inc (CDMO)

[Thurly]

Good point.

[EYEBUYSTOX]

FTM,

Is there any way to ascertain if this is true:

A significant number of patients in some arms of the 2nd line NSCLC trial were living longer than the typical MOS for docetaxel reported in other trials.

If so, it makes sense they would be in the bavi arms.

[newyorker1]

FTM - I believe you are correct that only the treatment arms were flawed. This would account to having data in both treatment arms that were close and needing pooled data IMO

Im holding on until further clarification. After all, the majority of patients are still alive...

[Protector]

Yeh, well that makes sense.

One could ask: If it wasn't for Bavi, what kept the patients alive.

If the control arm received Bavi and they shouldn't have then the control arm patients may actually have lived longer then they would have if they didn't receive Bavi.

The other way around, if the Bavi arms receive lesser Bavi because they got some placebo instead, then they could have lived less long as they would have if they got the dosages they where supposed to get.

If the mix up is between 1 and 3mg arms then the combined results are not affected as was posted before.

Could be that the 1mg arm received 3mg and the 3mg arm received 1mg. Then control arms are only to be reversed and no impact on results except another dosage would be advised in the end. This last case would be a result of a CONSISTENT error, which is needed through out the trial to have "MAJOR" discrepancies.

If the mix up is only on a part, or a geographically limited sample then again it will not have important impact because it can be singled out and depending on the mix up type be corrected.


So I was wondering if you, who understand all this much better then most of us, could comment on the above. I am sure there will be some form of mix up that can lead to lesser, not even necessarily bad, trial results, but I can't find that mix up (due to limited know-how).