great summary and points thanks dude. I agree with all that. Having designed and run 3 clinical trials myself (1 as PI and 2 as AI) I agree setting an endpoint is an art as much as a science. Go too small and you will need way to many subjects to recruit to get power and the trial will take forever. Go too large and you get it done but it doesnt make it like this one did. This happened with my first trial as well but with our 2nd we more than trippled the sample size so we could go smaller and closer to the MCID. The problem in this cutting edge stuff is that you are going 1st so you only have your own pilot trial to go off. not easy. Add to that the market and commercial pressures, its complex as shit. The market and the punters want black and white, while science and biology is shades of grey unforutnately. always IMHO. peace to all, I've drunk half a bottle of rum this weekend.... still pondering but think I will stay in at this point...
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great summary and points thanks dude. I agree with all that....
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