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Study results take almost two years to be released

By Genevra Pittman

NEW YORK (Reuters Health) - Results from the average clinical trial take almost two years to be published, according to a new study, despite U.S. regulations calling for a 12-month maximum lag time on the release of most research findings.

That's concerning, researchers said, because publication delays hinder doctors' ability to make the most well-informed treatment choices with their patients and slow progress within the scientific community.

"When trial results are withheld, either for years or - as commonly happens - forever, patients can suffer, because we can be misled about which treatment is best when the less flattering trial results go missing," said Dr. Ben Goldacre, a UK doctor and author of the book Bad Pharma.

Goldacre, who wasn't involved in the new analysis, told Reuters Health in an email that the Food and Drug Administration's 12-month limit for the results of clinical studies by U.S. investigators to be posted "has been widely ignored."

Even if it were to be enforced, he added, that law wouldn't allow doctors to access years of earlier clinical trial data that can be essential to informed decision-making but was never published.

For the new study, researchers led by Dr. Joseph Ross from the Yale University School of Medicine in New Haven, Connecticut, tracked the time between the end of data collection and the publication of more than 1,300 trials of drugs, devices and procedures.

The trials were all published in 2009. The average time to publication was 21 months, and was similar across studies funded by non-profits, the government or private companies, the researchers wrote Monday in JAMA Internal Medicine.

The analysis only included trials that made it into a journal - and the results of as many as half of all studies are never reported at all, Ross noted.

"Half (are) not getting published and even among the half that do get published, it still takes two years for the results to reach the public," he told Reuters Health.

"When a clinical trial is finished, it's at that moment that the information that the trial has generated is most useful to the public and to the research community," Ross said.

"Not only do patients and physicians need to incorporate that information into their treatment decision, but... you want the scientific community be aware of (the findings) before they start enrolling patients in another trial."

Ross said study funders could use their leverage to push for results to be released sooner.

As of now, he added, patients should be aware that "the information that's available to their physicians, that's informing the clinical decision that they can make with their physicians, is not all out there. It means you're not making a fully-informed decision."

SOURCE: http://bit.ly/YNEE4w JAMA Internal Medicine, online March 4, 2013.

(This story is fixed to changes the end of the fifth paragraph to reflect the reason doctors can't access old data is that it was not published.)

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