Thursday, July 25, 2024 6:06:12 PM
I disagree. The IA, ECA are not "scientifically" based rules. They are rules adopted and thought to make the trials better - not scientifically based. But others can differ on adopting the same logic - perhaps with different conclusions as to the procedural rules adopted. So one jurisdiction may think ECA is very important and not approve a trial that does not follow these rules. Another jurisdiction ,may agree with this logic but not go so far as to not approve a trial based on this. Yet another jurisdiction may simply frown on the practice but not even insist on them procedurally. Yet other jurisdictions may not even think they are really important and not consider them at all. These are not scientifically based rules as you claim. Same for the other considerations you mentioned - they are not based in provable science just some logical assumptions they believe will improve clinical trials. Others can differ as to their importance in approving trials.
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