TrixieStix
Senior Member (Voting Rights)
"Based on new draft guidance it seems that the FDA and NIH are teaming up in a big new way to punish those who are non-compliant with the Clinicaltrials.gov-related regulations and laws,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/
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/