This is trial as described is Ill advised I hope I am wrong. What does the consent look like no data and if you survive you can get cancer ?
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Replying to @rweichselbaum @MohammadKhanMD
Would love to hear the statistical justification for 5 patient enrollment and how you will *try* and figure out if the intervention did anything. With great potential for confounding factors and a single arm intervention I am shocked this made it through an IRB.
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As am I. Are fear of
#COVID-19 and desperation for any treatment leading IRBs to throw human research protections by the wayside, as long as it’s a COVID study? And how on earth are they going to see an efficacy signal in just five patients?
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Replying to @gorskon @BrandonADyer and
Well it is phase I so presumably primary endpoint is safety/feasibility, but agree with n=5 would be impossible to conclude anything meaningful. Which raises the question of whether risk to subjects/staff is justified. Hopefully there is more to this story.
1 reply 0 retweets 1 like
True, but they claim it's a phase I/II trial, which means they're at least going to try to see a signal of efficacy.
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