Only ABout1 Out of 10 Clinical Trials Met Federal Requirements to Report Their Findings on Time, Study

New research shows, researchers are not promptly reporting the results of clinical trials to a government website specifically created to make the findings of these studies known.

Only about 1 out of 10 clinical trials met federal requirements to report their findings on ClinicalTrials.gov within one year of the study’s completion. Study author Dr. Monique Anderson, a cardiologist at Duke University School of Medicine, in Durham, N.C. said, “We were really surprised to find that reporting certainly isn’t timely, and hardly anybody is doing it.”

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

Congress authorized the creation of ClinicalTrials.gov to publicly report information about clinical trials in 2000, the author said.  A new law expanded the website’s mandate, seven years later, requiring sponsors of most trials to report basic summary results, so Americans could have access to the data.

Anderson said, “There’s been a lot of concern that industry often withheld evidence that came to light later about their medical products, and that medical journals were selectively reporting the positive results from trials.”

Transparency has generally been poor among more than 13,000 clinical trials completed within the first five years after Congress expanded reporting requirements for ClinicalTrials.gov, Anderson and her colleagues said.

According to the study published in the March 12 issue of the New England Journal of Medicine, an average of 13 percent of eligible researchers reported their findings within the required one-year period. Private industry actually performed better than academic or publicly funded researchers in posting results, the study authors reported.

Almost 85 percent were designed to investigate a new treatment, and two-thirds of the trials were funded by private industry.

Findings show, the one-year reporting rate for industry-sponsored trials was 17 percent. Within five years, results had been posted for 41.5 percent of industry-funded trials.

By comparison, the one-year reporting rate was about 8 percent for clinical trials funded by the U.S. National Institutes of Health (NIH), and 6 percent for trials funded by academic institutions or other government agencies.

At five years, almost 39 percent of NIH-funded trials and close to 28 percent of academic/non-NIH-funded trials had reported results.

 

 

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