Sunday, 7 May 2017

Duke Dendritic Cell Vaccine Trial

I don't understand why they need to run another trial with a comparison group. Isn't median survival well established to compare it to?

1 comment:

  1. Small phase 1 trials like this often show much better results than larger trials with a larger, broader patient population. They (Duke University) are currently running a larger trial (45 patient estimated enrollment) for the CMV-targeted dendritic cell vaccine + tetanus shot + TMZ, with patients randomized to receive either 5 day or 21 day schedule of TMZ.

    Unfortunately even if this larger trial shows positive results it still won't likely be enough to get the vaccine FDA approved, they'll likely have to run a large multi-center phase 3 trial for that. My own position is that placebo controls are unethical for a disease like GBM, and that large, multi-center trials with no placebo arm could establish whether a treatment is superior to standard treatments alone, using some form of matched, contemporary, standard-treatment cohort for comparison. However drug development companies have to work with current regulations in order to obtain FDA approval.