The organic industry’s GMO hoax

[pnwmom]

137. It does for some drugs and biologics, but researchers apparently have been lax

about following the requirements.

http://www.seattletimes.com/seattle-news/health/study-uw-is-among-medical-centers-with-poor-clinical-trial-reporting-rates/

In the BMJ study, only 13 percent of academic medical centers nationwide posted study results on the federal website. At the UW, just 18.4 percent of studies were reported on ClinicalTrials.gov, but at OHSU, the figure was nearly 51 percent.

“This paper brings to light that the institution has a responsibility,” said Dr. Deborah Zarin, director of ClinicalTrials.gov. “They used to leave it to individual investigators.”

Part of the trouble is that there have been few incentives to encourage reporting or consequences for failure to do so. Under the federal Food and Drug Administration Amendments Act of 2007, results of certain trials are required by law to be reported within a year of completion, and researchers can be fined up to $10,000 a day per trial for lapses. But, so far, no fine has been levied.

New rules are expected soon aimed at strengthening reporting of clinical trials funded by the National Institutes of Health and regulated by the Food and Drug Administration.

https://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhichTrialsMustBeRegistered

Results Deadlines

In general, results of an Applicable Clinical Trial of a drug, biologic, or device that is approved, licensed, or cleared by FDA must be submitted by the Responsible Party no later than 12 months after the Completion Date (see Primary Completion Date data element on ClinicalTrials.gov).

See the statutory provision for Completion Date (PDF).

FAQ: How do I submit results information if the trial is terminated (that is, stopped prematurely) and no data were collected for one or more Outcome Measures?