Regulatory Focus™ > News Articles > FDA Disputes Study Findings, Goes After Some Clinical Trial Sponsors

FDA Disputes Study Findings, Goes After Some Clinical Trial Sponsors

Posted 02 May 2012 | By Alexander Gaffney, RAC 

Months after the British Medical Journal (BMJ) reported that the US Food and Drug Administration's (FDA) oversight of its clinical trials database was suffering from serious lapses in clinical trial reporting and transparency, US regulators are firing back, charging that the studies' authors "overstated non-compliance with data reporting laws," reports Nature.

The studies published in BMJ found some troubling occurrences, including a 78% non-compliance rate with data reporting laws, an approximately 50% reporting rate for studies sponsored by the National Institutes of Health (NIH) and the presence of publication biases in unpublished studies.

FDA responded that the BMJ studies took into account some trials that were not legally required to comply with the reporting laws, including trials completed before the law's implementation and trials conducted on unapproved products, reports Nature.

"The authors, in addition, included some trials for which data had been submitted but not yet vetted by NIH," explained Nature. "Finally, the BMJ authors could not tell, from the data in, whether a sponsor's submission deadline had been extended; the law allows this when an approved product is being tested for a new indication."

FDA is partially owning up to the results however, and is "pursuing [fifteen] individual responsible parties" for their failures to post results to the website in the mandatory time frame.

Another counter-intuitive finding supported by the original BMJ analyses and NIH: industry sponsors report the results of their studies to at a higher rate than do NIH-based and -funded sponsors. Industry reported 52% of the time within the mandatory reporting period, while just 21% of NIH-based and 14% of NIH-funded sponsors reported within the mandatory reporting period.

"The academic world is probably doing a worse job of reporting than industry," says Deborah Zarin, director of  "And that's consistent with what BMJ found."

Read more:

Nature - FDA says study overestimated non-compliance with data-reporting laws

Regulatory Focus - BMJ: Lack of Research Transparency Breaks Regulations, Hurts Patients

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