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justcurious

332 Posts.

17

25/05/20

17:03

Post #: 44822889
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Originally posted by JonesingPanda: ↑

I think I've figured out the minimum number of patients in the first interim results needed to survive by day 30 for the COVID trial to be deemed statistically significant... take this with a grain of salt though.

90 patients in first interim, split 1:1 randomised, 45 treated with remestemcel and 45 treated with standard care (placebo group):
If the 12% survival rate in non-treated patients is reflected in the 45, that's only 6/45 expected to survive.
A minimum of 14/45 of the patients treated with remestemcel need to survive to achieve a p-value of 0.05 (statistically significant result).

That's only 31% survival needed... the bar is low.
To compare, remestemcel in the small cohort of ARDS saw a 75% survival, in aGvHD it saw a 67% survival rate at 100 days.

My maths is shaky, but if that's correct we only need less than half of the survival rates already seen in other trials to be deemed a significant treatment. Just try and convince me that it's unlikely to be a success.

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My opinion is that a p-value of 0.05 wouldn't be enough in a small sample like that to qualify for overwhelming efficacy. How many would need to survive to make the p-value <0.01?

MSB Price at posting: $3.68 Sentiment: Hold Disclosure: Held
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