Most Medical Study Authors in US Still Failing to Comply With Legal Obligations

Rob Wipond
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The majority of clinical trials are still not reporting their results to the US government’s ClinicalTrials.gov website, despite legal requirements that they do so, according to a study in the New England Journal of Medicine.

“From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs (highly likely applicable clinical trials) that were terminated or completed from January 1, 2008, through August 31, 2012,” the researchers wrote. “Of these trials, 77.4% were classified as drug trials.”

They found that “an average of just 13.4 percent of eligible trials reported findings within the required one-year window” for reporting, stated a Duke University press release about the study. “For industry-sponsored trials, the rate was 17 percent. It was 5.7 percent for trials funded by academic or government sources other than the (National Institute of Health) and 8.1 percent for NIH-funded trials.”

Compliance did improve somewhat over time. “At five years, 41.5 percent of industry-funded trials, 27.7 percent of academic/non-NIH-funded trials, and 38.9 percent of NIH-funded trials had reported results,” stated the press release. “Study authors said the lack of transparency by industry, federal funders and academia has created a critical information gap about investigational drugs, devices and biologic therapies that not only hampers progress, but also violates obligations to patients.”

Clinical trial sponsors fail to report results to participants, public (Duke University press release on MedicalXpress, March 11, 2015)

Anderson, Monique L., Karen Chiswell, Eric D. Peterson, Asba Tasneem, James Topping, and Robert M. Califf. “Compliance with Results Reporting at ClinicalTrials.gov.” New England Journal of Medicine 372, no. 11 (March 12, 2015): 1031–39. doi:10.1056/NEJMsa1409364. (Abstract)

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