Replies to post #129039 on Avid Bioservices Inc (CDMO)

[jq1234]

That's a GREAT question! There are many different ways to do randomization. The best way to ensure balanced arms is via stratification during randomization, for example stratify by ECOG, disease stage, race etc to ensure different arms are balanced by these basic factors. It doesn't seem they stratified in their randomized trials, which is why many on this board complained the so called imbalance for example ECOG between arms. Whose fault is that? I guess if they were stratified, no one could find excuses to explain away things anymore.

[exwannabe]

Do you know how they randomize it?

They predefine what are the "stratification factors", these will be evenly divided between the arms. I would assume (but do know know) that stage would likely be balanced between arms.

I also assume there are practical issues with trying to balance too many factors. You do need to get a patient in an arm "real time" , and can not wait to see the entire population then split it up.

EDIT: To jq's reply on this:

I both agree and disagree. I think one might question them on the ECOG-2 issue. But it is not possible to know all the trial design questions, and we might be Monday morning quarterbacking by doing such.

As I said, I doubt they can just stratify everything.