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FDA outlines potential crackdown on Clinicaltrials.gov offenders

Discussion in 'Research methodology news and research' started by TrixieStix, Sep 23, 2018.

  1. TrixieStix

    TrixieStix Senior Member (Voting Rights)

    Messages:
    245
    "Based on new draft guidance it seems that the FDA and NIH are teaming up in a big new way to punish those who are non-compliant with the Clinicaltrials.gov-related regulations and laws, including potentially with large fines.

    What do sponsors of specific listings do that’s so bad?

    There are a variety of problems including submitting false information or certifications as well as failure to post results in some cases as documented in a 2015 NEJM Anderson, et al. pub by the FDA itself, and other issues. See Figure 2 from the Anderson pub showing the poor reporting compliance of results."

    https://ipscell.com/2018/09/fda-outlines-potential-crackdown-on-clinicaltrials-gov-offenders/
     
    alktipping, Sean, Samuel and 6 others like this.

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