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Re: loanranger post# 249797

Monday, 11/26/2018 9:45:17 AM

Monday, November 26, 2018 9:45:17 AM

Post# of 403047
What I meant was: Depressing number of pharmaceutical companies treat trial registry as nuisance and in violation of regulations do report very little or nothing. And why not: as far as I know before 2017 FDA had not issued single fine for violations.

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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