New rule on clinical trial reporting doesn't go far enough
lterrat's bookmarks 2017-01-18
"A recently passed final rule from the Department of Health and Human Services now requires that all NIH-sponsored clinical trials be reported on ClinicalTrials.gov. A complementary policy from the National Institutes of Health covers registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not covered by the final rule.
Unreported trials are subject to daily fines of $11,833. Researchers have 90 days after the rule is enacted on January 18, 2017 to comply with it. Excellent summaries of the rule have been published by the NIH and in the New England Journal of Medicine.
The final rule should help address some of the troubling trends in the clinical trial industry. It clears up ambiguous reporting requirements and explicitly requires investigators to submit clinical trial results, adverse events, and statistical methods. These are steps in the right direction that could limit the unscientific practices plaguing the trial industry.
But the final rule doesn’t go far enough, mainly because FDA lacks the staff and the political will to adequately enforce it. As STAT reported in December 2015, the FDA had never levied a single fine for clinical trial reporting violations. Representatives from the FDA cite legal complexities and lack of employees, yet critics have also pointed out the FDA is effectively on the pharmaceutical industry’s payroll. Under the Prescription Drug User Fee Act, the FDA supplements its budget by charging pharmaceutical companies drug application fees that totaled $855 million in fiscal year 2015."