Avid Bioservices Inc (CDMO)

[exwannabe]

The patient assignment to the arms have a huge impact on the results as was demonstrated a few posts ago. Would the patients FIRST have been grouped in ECOG groups and each arm would receive an equal number of 0,1 and 2 patients then the external factor would have been eliminated. Hard to do because it would imply that you know the ECOG of all patients that are going to show up during the enrollment period in advance, which isn't the case. Assigning them on the fly with a toggling technique is possible but would open the clinical trial to a certain degree of 'fixing' because in a non-blinded trial if two patients of a same ECOG group show up one could systematically assign the less sick one to the Bavi arm and the other to the control arm. To make this possible an provision that isn't available today for clinical trial would be needed.

Stratifying based status, age, sex, etc., is very common. To claim this can not be is nonsense.

If the problem with this trial was the ECOG=2 patients, ask PPHM why they even allowed them in the trial