Clinical Trial Data Repressed

A new study finds that important drug safety data are not seeing the light of day.

By | January 5, 2012

SEATTLE MUNICIPAL ARCHIVES FROM SEATTLE, WA

Data from early stage clinical trials are not being widely reported, thus putting patients at risk, according to a handful of new studies in the British Medical Journal. The missing data includes both safety and efficacy findings that go unreported or are published in obscure places. "This is no academic matter, because missing data about harm in trials can harm patients, and incomplete data about benefit can lead to futile costs to health systems," wrote Oxford University researcher Richard Lehman and BMJ editor Elizabeth Loder in an editorial accompanying the studies. "Moreover, researchers or others who deliberately conceal trial results have breached their ethical duty to trial participants."

These deficiencies surface even after the US Food and Drug Administration enacted rules in 2007 to mandate the posting of all clinical trial data on ClinicalTrials.gov within 12 months of the studies' conclusions.

In one of the BMJ studies, researchers found that only 22 percent of trials registered on ClinicalTrials.gov in 2009 had results available a year after being completed. And fewer than half of all National Institutes of Health-funded trials are published in a peer-reviewed journal within 30 months of completion, another study reported.

"When the word 'mandatory' turns out to mandate so little," Lehman and Loder wrote, "the need for stronger mechanisms of enforcement becomes very clear."

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