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comment by kleinbl00
kleinbl00  ·  1589 days ago  ·  link  ·    ·  parent  ·  post: A Vision of Healthcare In a Post COVID-19 World - Scientific American

Aimmune thought things would be awesome if they came up with an app that you could record when your kid took their dose. Then it threw a couple errors. Then the FDA said people had to enter their shit into the app, because it was protocol, and also write it in a journal. And the clinicians had to compare the two. Then a year later they managed to get it so they could drop the app, but not fix the app, because it had been erroneous. Then two years later they finally got to the point where you didn't have to write down exactly what time you'd dosed, just whether or not you hadn't. That's for a dose of characterized peanut protein that your test subject has already demonstrated tolerance to in a clinical setting.

That clinical setting? BP before, during and after. 3 hours of monitoring. Can't leave without an epipen. Epipen in your car? Show it to me. Expired epipen? have a new epipen.





b_b  ·  1589 days ago  ·  link  ·  

And every. single. one. of those changes required a protocol amendment, which probably required a data review, which probably necessitated at least a phone meeting with FDA. Now multiply that by as many studies as there are registered on clinicaltrials.gov. FDA has a hard job, and putting the controls in the hands of laymen will not make it easier.

kleinbl00  ·  1589 days ago  ·  link  ·  

On a scale from "thalidomide" to "Vioxx" I much prefer my FDA to operate closer to the thalidomide side.