The meaning of more patients is huge. I am glad N
Post# of 148175
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Posted On: 06/16/2020 7:37:45 AM
The meaning of more patients is huge. I am glad NP reads mails and we had the good fortune of an accelerated recruitment.
If we want to be approved the fact that we might have 85-90 patients by tomorrow can't be overstated … Why ?? The power of the trial goes up considerably (the same way it would have gone down if we had less than 75 patients).
Throwing numbers is sometimes risky as one has to make several assumptions, but using reasonable numbers (Mean Placebo=7.4; clinically significant change=1.31, Standard deviation=1.9) I obtained that, if we had had say, 68 patients , the power would have diminished to 71% (normal power required for a trial is 80% or even 90%).
Again, the “power” is simply the probability that Leronlimab works and we think (conclude) that it doesn't (so called Type II error).
So, how does increasing the number of patients help ??. Well, obviously the trial with 75 was designed to achieve an acceptable power, if he number of patients increase this goes higher.
Once again, using the same assumptions, the addition of 5 patients can increase the power in approximately 6%. As we know, it is critical for us to have extremely good results as this is P2 and we need FDA to approve Lero in basis of these.
The number provided above are just approximations, of course, as I have made the assumptions depicted above, is just for illustration purposes only.
Let's hope we will have a super-duper trial ... we are almost there.
If we want to be approved the fact that we might have 85-90 patients by tomorrow can't be overstated … Why ?? The power of the trial goes up considerably (the same way it would have gone down if we had less than 75 patients).
Throwing numbers is sometimes risky as one has to make several assumptions, but using reasonable numbers (Mean Placebo=7.4; clinically significant change=1.31, Standard deviation=1.9) I obtained that, if we had had say, 68 patients , the power would have diminished to 71% (normal power required for a trial is 80% or even 90%).
Again, the “power” is simply the probability that Leronlimab works and we think (conclude) that it doesn't (so called Type II error).
So, how does increasing the number of patients help ??. Well, obviously the trial with 75 was designed to achieve an acceptable power, if he number of patients increase this goes higher.
Once again, using the same assumptions, the addition of 5 patients can increase the power in approximately 6%. As we know, it is critical for us to have extremely good results as this is P2 and we need FDA to approve Lero in basis of these.
The number provided above are just approximations, of course, as I have made the assumptions depicted above, is just for illustration purposes only.
Let's hope we will have a super-duper trial ... we are almost there.
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