FDA doesn’t routinely notify journals of irregularities in clinical trials

FDA doesn’t routinely notify journals of irregularities in clinical trials


Before a study is published in a peer-reviewed medical journal, it’s carefully reviewed and revised.

If the editors become aware of a problem afterward, they can print a correction.

But if someone finds a problem and never tells the editors, there’s nothing they can do.

This troubling scenario seems to have been exactly what happened with dozens of flawed studies, according to an article published in the journal JAMA Internal Medicine.

The article focused on 57 clinical trials that took place between 1998 and 2013. Inspectors with the U.S. Food and Drug Administration visited the trial sites and found serious problems, sometimes including false data or the failure to report adverse events properly.

The authors of the JAMA article learned about these inspections from documents they obtained via the Freedom of Information Act.

Then, the authors searched medical journals for studies that contained the names of the researchers and trial sites mentioned in the documents.

When the authors found a study that resulted from one of the clinical trials, they checked for any mention of the F-D-A inspection results.

In total, the 57 clinical trials gave rise to 78 published articles. Only three of those articles mentioned any problems noted by the F-D-A inspectors.

According to the authors, the F-D-A does not routinely notify medical journals or the public when inspectors find serious problems with clinical trials.

The authors argue that this information should be more easily available.

Doctors sometimes rely on peer-reviewed studies when making treatment decisions for patients. So patients should be sure to discuss medical decisions thoroughly with their physicians before deciding on a plan of action.

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