NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Enrollment can have different meanings depending on context.
Some use it to mean when you sign the consent form you are enrolled, but that comes at the start of screening, and does not necessarily mean you will be randomized. Recruitment also has vague meaning.
Randomization is the more usual term for confirmed joining of an RCT trial, when you have passed all screening.
In GBM, the later you leave randomization, the more time you have to weed out early progressors...
Chemorad takes place during the gap from surgery to randomization
Optune went 3.8 months from diagnosis/surgery to randomization. The longest I have seen anywhere. They had two scans before randomization and allowed entry to confirmed pseudo-progressors at the same time as excluding rapid progressors. Starting the clock from randomization can also make your PFS comparison look better. But it will make OS12 look worse at a quick glance.
All their figures are from randomization.

All the DCVax figures are from surgery. Median gap from surgery to randomization in the DCVax trial was 3.1 months.

So all that has to be born in mind when comparing the milestone figures between Optune and DCVax.

https://firstclinical.com/fda-gcp/?show=2013/RE%20Request%20for%20guideline%20or%20regulation%20for%20when%20exactly%20a%20subject%20is%20considered%20enrolled%20into%20a%20clinical%20study&format=fulllist