Lecture 3 - FDA Drug Approval 101- Reading and Interpreting Cancer Trials Series
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- Опубликовано: 25 авг 2024
- Vinay Prasad, MD MPH
HemeOnc Doctor & Associate Professor of Epi/ Biostats
Host of Plenary Session Podcast
/ plenarysession
Twitter @vprasadmdmph
Tell it brother! One of the few brave enough to speak the truth about oncology clinical trials and FDA approvals.
It's the doctors fault for buying into it
Episode 4 pleeeaaase! This is the best series for gemonc fellows
Thank you for making these public Dr. Prasad much appreciated
we want lecture 4! please. I am getting so much out of these that I wish I had learned in medical school.
Thank you for creating this lecture series! Your arguments are interesting and convincing. I am interested to hear what you would say if you were forced to steel man the argument in favor of using PFS, DFS, RR, and other surrogate endpoints? Here is my attempt: Even if PFS only shaves off 11 months on average in getting drugs to market, there are some outliers in that average that using PFS might be worth it. The same goes for PFS's usefulness as a surrogate for OS. There are going to be some outliers on the plot of delta PFS vs. delta OS in which a drug is on or above the R2=1 line. I agree that on average the time saved in bringing drug to market and value as a surrogate is poor for PFS, but maybe there are markers that could be used to predict for what drugs PFS will be a very good surrogate.
I am an incoming first year medical student, so forgive me if my lack of knowledge in this space is apparent in my question. I'm looking forward to lecture 4!
Reading Malignant answered my questions!
Great lectures! I'm going into my 3rd year of pharmacy school and thinking of pursuing an oncology residency. All have been hugely beneficial to me. Looking forward to the rest of them soon!
Greetings from Uganda
Great lecture, keep the coming please!
I take your point about time to market, but I'm not sure the 11 month figure captures the full benefit a drug manufacturer sees from using these surrogates. When the FDA approves a drug with with single arm Ph1b/Ph2a RR data, the manufacturer gets access to it's most lucrative market (the US) in a fraction of the 'normal' time. This completely changes the payback horizon and IRR calculations. So why not "go for it"? Coupled with the near zero accountability for follow-up, it's a no-brainer for the mfg.
Bring on Lecture 4
Is the lecture 5 on the Plenary Session podcast from this series? You refer to lecture 4 in it for something important that I found hard to follow - will you be putting out 4, too, or maybe I just don’t know where to find it?
When do we get lecture 4??
Vinay: MY LIFE IS ALL A LIE !!! Hahaha - but seriously thank you from the bottom of my left ventricle - I am buying MALIGNANT immediately - #PROUD of your work and your presentation style.