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Monday, November 26, 2018 9:45:17 AM
I, for one, hope the new rules in effect since January 2017 will improve situation. May be futile, thou.
current trial registration regulations:
https://www.ecfr.gov/cgi-bin/text-idx?SID=e617ec4da22678f934787ed565bbaa5a&mc=true&node=pt42.1.11&rgn=div5
Trial protocol is THE DOCUMENT that specifies ALL outcome measures in a given trial. It must be approved by FDA before a trial can commence if the drug is intended for sale in USA. So FDA does know, very often we don't.
"I would rather have questions that can't be answered than answers that can't be questioned." Richard P. Feynman
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