Every trial is different. Ebery disease is different. And every company is different. It is unique to Phase iii trial in GBM that had progression as it primary endpoint (which would require review of scans to be included in the analyze and not just a pulse) it would take much longer. And because this one does and is considered large (when one considers the number of places the study recruited) it would also mean a much busier travel schedule with more stops. And because they are a small biotech, it will likely mean they only hired the bear minimum of a team to perform such function. And so yes, I do see this as s multi-month process. Again, depends on how many they are able to close out a week /a month.
They have two CROs. One for international and one for the US. And then Marnix is on point to review data at his discretion. We don’t know how many people from each CRO agency is on NWBio acct. But whatever it is I imagine it’s not many full time. They have to go to every single clinical site in the trial and there are over 80 clinical sites in four counties. They will need to make sure scans are in for every patient. And what they have to review is substantial considering most patients have lived 2 years or more and the study duration started with possible as much as 11 years of MRI data on some patients (if we make an assumption that some of the 2008 -2010 patients are still alive. This isn’t Stupp, where a handful of sites recruited majority patients. Well over 1000 people were recruited. No site in this trial has more than UCLA targeted 28 patients. They have to make sure they have all the immune testing data on each patient. Go over crossover data. Lots of material. And again it’s not straight survival they will need to review is eCFs. And so yeah, I see it as s cumbersome timely collection process.
Off the protocol:
Parexel International, a contract research organization, will assist the sponsor in
performing the sponsor responsibilities in the EU (site selection, clinical
monitoring, pharmacovigilance, submissions to the ethics committees, and
clinical data management) noted in the regulations.
.Synteract, Inc., a contract
research organization, will assist the sponsor in performing the sponsor
responsibilities in the U.S. (site selection, clinical monitoring, pharmacovigilance,
regulatory submissions, and clinical data management) noted in the regulations.
