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11/22/2024 12:12:41 am

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Academic Research Fails to Report Majority of Clinical Results

National Institutes of Health

(Photo : REUTERS/GARY CAMERON) The patient's entrance at the National Institutes of Health is shown in Bethesda, Maryland.

Researchers found the vast majority of clinical trials fail to have their results posted to the main federal registry, Clinicaltrials.gov, within a year of completion as required by law.

"My savvy cardiology patients want to know about the results of clinical trials, and how these results will affect them. If we're making a promise to make those results available, we should uphold that promise," said study author Dr. Monique Anderson, a cardiologist at Duke University School of Medicine, in North Carolina.

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Study authors reported that private industry actually performed better than academic or publicly funded researchers in posting results.

Out of more than 13,000 completed or terminated trials in the registry from 2008 to 2013 subject to the reporting requirement, result summaries for only 13.4 percent appeared there.

"The medical-products industry has been more responsive to the legal mandate of the FDAAA [Food and Drug Administration Amendments Act]. However, industry, the NIH, and other government and academic institutions all performed poorly with respect to ethical obligations for transparency," explained Anderson and her colleagues.

"The study confirms the need for the NIH's newly proposed policy that requires all NIH-funded investigators to submit clinical trial results information or risk losing their funding."

Kathy Hudson, PhD, NIH Deputy Director of Science Outreach and Policy, said poor results reporting of NIH-funded clinical trials to ClinicalTrials.gov is purely unacceptable.

"The study confirms the need for the NIH's newly proposed policy that requires all NIH-funded investigators to submit clinical trial results information or risk losing their funding," Hudson added.

Compared with NIH-supported trials, industry-funded trials were more likely to report results at the requisite one-year mark, although more industry trials were exempt from the reporting, and these reporting differences vanished after five years, researchers also found.

These delays can rob patients of valuable information needed to treat serious and potentially life-threatening ailments, Anderson said.

The reporting requirements for ClinicalTrials.gov do allow researchers to delay submitting their data if they want to market a new drug or device and are awaiting approval from the U.S. Food and Drug Administration.

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