.
Thanks to Aurel and Hottod for excellent and very informative posts.
I have a concern in the design of the P3 trial which you might be able to help me resolve, which is why in a 180 participant trial is there a 90 /90 active versus placebo split?
We are trying to get the best -defined and reliable measurement of the difference between the 2 sample groups, but I feel intuitively that we don't need such a large placebo sample size.
The previous P2 trial surely provides placebo behavioural data which we could directly plug in to the P3 trial as results, or at very least it would provide data on the likely placebo effect characteristics (if any) such that we can accurately estimate the placebo number of patients necessary. For example, if we can calculate that a placebo sample size of (say) 40 patients would be enough, then we can give Trofinetide to 140 patients.
Wouldn't this give a more reliable result? ... and assuming Trofinetide works well then we have 50 more kids who have been helped?
I know the professionals at Arcadia (and Neuren too) know what they are doing, but I am curious as to why.
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