This is a really good take. There are couple of things about this trial that dont quite sit right. Some of this recaps the above thoughts
1) COI among the authors (that doesnt necessarily mean the results arent believable but its at least worth noting. And this is obviously a non blinded study.
219 were randomly assigned to IMRT. 136 (62%) were treated with IMRT.)
1a) I also dont understand why 22 are denied insurance when i thought clinical trials should be covered by insurance??
1b) the language in the publication and in some of the posts online is very strong and the results are overstated:
Proton Therapy Breakthrough in Head and Neck Cancer Treatment | Michael Marash posted on the topic | LinkedIn
3) Why is it claiming superiority ("improvement in overall survival") when its a noninferiority study design? how can you have a "new standard of care treatment" when its a non-inferiority study design? Wouldnt you want to design the study to show that IMRT is non-inferior to IMPT for practical reasons (you would want to show the lower cost, widely accessible technology is the non-inferior one, right?). Why is the primary endpoint and oncologic one (PFS) opposed to QoL (is the premise that IMPT would be inferior for cancer control? this doesnt make sense to me) I feel like Im taking crazy pills and needs someone smarter than me (a statistician) to explain/justify all this.
Here are the curves for their primary endpoint:
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