dfwl28, Remember Remdesivir ??? Has been SOC b
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Posted On: 01/07/2021 7:22:48 PM
dfwl28,
Remember Remdesivir ??? Has been SOC because it "trended positive". Dr. Faucci's own words in the oval office, and I am not exaggerating.
As I mentioned before p-value should be flexible but it is not (it is more or less rock solid with few exceptions). Why ??? The enormous economical interests. With billion dollars the FDA has to answer questions like: why my drug with p-value 0.058 was not approved ??? and this other with 0.06 was ???
The very question of using a one or two tailed test is on itself substantial. In many occasions a one-tailed test should suffice.
Power is different as the number of trial patients depend to a great extent on the condition being treated, costs, number of end-points and availability of patients. Case in hand: our CD-12 would be much better powered with 1000 patients. However, is it practical ?? How long would it take ?? What are the costs ? (human and economical). And so on. The trial is designed with a "good" power in mind taking into account all the practicalities.
So, there might be some flexibility in this area. As a matter of fact, a range is normally mentioned for this value. Now, Pandemic in hand, I believe the FDA will be amenable to some extra flexibility.
Just mi opinion, of course.
Remember Remdesivir ??? Has been SOC because it "trended positive". Dr. Faucci's own words in the oval office, and I am not exaggerating.
As I mentioned before p-value should be flexible but it is not (it is more or less rock solid with few exceptions). Why ??? The enormous economical interests. With billion dollars the FDA has to answer questions like: why my drug with p-value 0.058 was not approved ??? and this other with 0.06 was ???
The very question of using a one or two tailed test is on itself substantial. In many occasions a one-tailed test should suffice.
Power is different as the number of trial patients depend to a great extent on the condition being treated, costs, number of end-points and availability of patients. Case in hand: our CD-12 would be much better powered with 1000 patients. However, is it practical ?? How long would it take ?? What are the costs ? (human and economical). And so on. The trial is designed with a "good" power in mind taking into account all the practicalities.
So, there might be some flexibility in this area. As a matter of fact, a range is normally mentioned for this value. Now, Pandemic in hand, I believe the FDA will be amenable to some extra flexibility.
Just mi opinion, of course.
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