Friday, October 31, 2014 4:36:25 PM
I'm glad everyone continued the conversation on Dr. Ashkan Keyoumars' research paper after I went to work this morning.
As for his disclosure, it appeared at the bottom of the original research paper published in PubMed on July 7, 2014, however, it obviously is not at the bottom of the one which is on Landes Bioscience website, which you kindly gave us the link. I have a habit of cutting and pasting articles/info I like and usually put the URL with it. I think this was e-mailed to me on my request, but I can't seem to repeat it at PubMed.
So, I can't link you to the original article, just the abstract. If anyone else can extract the entire article from PubMed, it would be interesting to see if the disclosure is still there!
Anyway, my original question is this:
Does 4 months PFS in Phase III for DCVax-L actually equal 7 months PFS in the previous Phase I/II?
I think Dr Ashkan is saying that in this research paper.
When I read this I assumed "common clinical practice" refers to how Phase I/II was conducted (as well as other clinical trials) because there was no randomization in that trial.
It's probably a mute point because I think we all believe DCVax-L will meet its PFS endpoint(whether 4 months is actually 7 or just 4), as well as its OS endpoint. I just want to put it out there in case they don't meet it, or it appears too close for comfort. I also checked the FDA guidelines and they definitely require PFS to begin at randomization.
As far as what goes on during those 3 months - I know that Linda Powers has laid it out very clearly and it may also be laid out in the clinical trial data. I've read it several places - the SOC gets done before patients can move on with DCVax-L treatment.
At any rate, I was very happy to see the endpoint moved to 4 months, partly because of Dr. Ashkan's comments in this paper.
P.S.: If anyone still needs me to reprint the entire paper, I can, but the link to Landes BioScience seems to have the entire paper....minor the disclosure...
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