Clinical Trials with No Results and No Fines Levied

Effective in Feb 2018, the FDA is mandated to fine up to $10,000 per day for failure to post results of studies registered with Clinicaltrials.gov within 13 months of the conclusion of said studies.

Aside from the failure to enforce their own rule (FDAAA 2007),  shunning a source of operating funds, there is the harm done to the advancement of medicine.

An outfit called AllTrials is urging the FDA to enforce their own rule and going a step further in the absence of such enforcement by publishing and updating a list of entities that are in violation of the rule (OPK is not, as of today, on the list).  Along with that, they publish a running total of the fines that could have been assessed.

@fdaaatracker

Who’s sharing their clinical trial results?

The NIH, per above, is withholding funds from academic, some private, trial sponsors for failure to publish results.

The FDA? Not so much.