Labs Rarely Report Clinical-Trial Data on Time

According to United States law, studies of potential medicines and diagnostics are supposed to make their results publicly available within 12 months. But up to half of studies don’t follow the rules—and no one has ever faced penalties.
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(Photo: isak55/Shutterstock)

(Photo: isak55/Shutterstock)

Scientific studies that show something doesn't work—Alas! Snake oil doesn't cure impotence, after all—are much less likely to get published. Drug companies may keep such data quiet, or scientific journals may be unwilling to accept papers with negative results because they're not as exciting. Over time, this pattern creates the impression that certain medicines are more effective than they really are, because there are no papers out there saying otherwise.

Case in point: In 2008, a team of researchers found that 94 percent of published clinical trials about antidepressants showed that they work. Yet antidepressant clinical trials fail 49 percent of the time, according to United States Food and Drug Administration data. Discrepancies like that were part of the reason lawmakers passed the FDA Amendments Act in 2007, which requires experiments that measure whether treatments and diagnostic tests work in people make their results publicly available within a year of the experiments' end. In fact, anybody is supposed to be able to see those results on ClinicalTrials.gov.

So have scientists been following the rules? A new study finds they haven't. Up to 45 percent of university- and government-funded trials don't report results like they're legally mandated to, according to the analysis by Duke University researchers. About one in five drug and device company-funded clinical trials don't report results, either.

"We are really grateful to patients who participate in this research. I think this is the way we uphold our part of the bargain."

And those numbers are just for the trials that the law clearly says must report results. There are loopholes in the law that government health agencies are working to close, says Monique Anderson, a Duke cardiologist who led the study, published yesterday in the New England Journal of Medicine. Once those loopholes close, the numbers of non-compliers will be higher.

Anderson has a sense of how high. In her study, she checked reporting rates among more than 13,000 studies involving testing drugs, devices, and diagnostic tests in people. Just 13 percent reported their results within a year. Only 38 percent ever published results within the time frame Anderson and her colleagues studied. Although not all of those non-reporters were technically flouting the law, Anderson believes they're dodging a moral responsibility. "Ethically, pretty much everybody should be reporting their results," she says. "I just think that it's awesome to be able to have participants help to figure out innovative new treatments. We are really grateful to patients who participate in this research. I think this is the way we uphold our part of the bargain."

Hopefully, these numbers will improve soon. Although it's been eight years since the FDA Amendments Act passed, no lab has yet faced penalties. The act says labs could pay up to $10,000 a day and lose any funding they have from the National Institutes of Health. This January, the Department of Health and Human Services published a detailed regulation proposal that clarifies whom the act covers, and could pave the way for harsher punishments.

Quick Studies is an award-winning series that sheds light on new research and discoveries that change the way we look at the world.

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