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b_b  ·  1344 days ago  ·  link  ·    ·  parent  ·  post: A Vision of Healthcare In a Post COVID-19 World - Scientific American

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.