Most Medical Study Authors In US Still Failing To Comply With Legal Obligations

madinamerica;

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)

--Rob Wipond, News Editor

This entry was posted in Bias, Corruption & Accountability, Featured News, In the News, Industry,Research, Uncategorized and tagged Google News. Bookmark the permalink. 

RELATED POSTS

Report on University of Minnesota Psychiatric Research Practices “Scathing”March 21, 2015

Psychiatrists Discuss Psychiatry’s Poor Public Image and What to Do About ItDecember 24, 2014

Nurse with Secret Recordings Exposes More about University of Minnesota Research ScandalDecember 1, 2014

“Alarm and Disbelief” as New EU President Moves Regulation of Medicines to Industry MinistrySeptember 18, 2014

Integrating Mental Health and Development in NepalJuly 11, 2012

Thank You Mr Wipond and MIA.