Sunday, December 11, 2011
The federal government is not getting the disclosure it had hoped for clinical trials when it mandated four years ago that researchers register studies of prescription drugs and report results on ClinicalTrials.gov.
Of the studies submitted to the federal database, only 12% were reported within a year of the trials’ completion, as required under law. Thirty-nine percent were submitted late.
Experts have recommended that the Food and Drug Administration (FDA) adopt tougher penalties to force companies and academic institutions to comply with reporting results in a timely manner.
But then again why bother when the government hasn’t levied any fines at all to date for those failing to submit results as mandated. The FDA can already impose civil fines of up to $10,000 a day for violations, but hasn’t done so.
-David Wallechinsky
Despite Mandates, Few Study Results Are Reported (by Ed Silverman, Pharmalot)
Despite Law, Fewer Than One In Eight Completed Studies Of Drugs And Biologics Are Reported On Time On Clinical (by Michael Law, Yuko Kawasumi and Steven Morgan, Health Affairs)
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