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Many FDA-Approved Drug Trial Reports Go Unpublished Causing Bias

Sep 25, 2008 | Parker Waichman LLP

A study conducted by University of California, San Francisco (UCSF) researchers states that selective reporting of drug clinical trials may bias comparisons to other medications.  The researchers also state that over half of all supporting clinical trials for U.S. Food and Drug Administration (FDA)-approved drugs have remained unpublished as long as five years after permission has been granted to sell those drugs in the United States. Study findings were published in the journal PLoS Medicine.

As part of their research, the team reviewed medical literature to determine the publication status of all 909 clinical trials that supported the 90 new drug applications that were approved by the FDA in the years between 1998 and 2000.  The group found that 76 percent of all key trials—for example, large Phase II and Phase III trials, which are designed to determine a drug’s overall risks and benefits—were published in medical journals, usually within three years of FDA approval of the drug.  Interestingly, less than half—only 43 percent—of all supporting trials submitted to the FDA were published.

The UCSF team also revealed that there were incidences of selective reporting of the results from these trials.  This means that in a key trial in which a new drug was found to have outperformed an old drug, the findings were likelier to be published than, say, results from a trial indicating that a new drug performed no better than its older counterpart.  According to the UCSF researchers, Publication biases such as this can lead to records inaccurately appearing favorable in the medical literature discussing one drug’s performance over other medications and can also lead physicians to favor newer and more expensive medications over older, proven drugs.

The UCSF researcher team says that their findings are providing a starting point with which to begin monitoring the effects of the FDA Amendments Act of 2007, which was introduced to improve accuracy and totality of drug trial reporting.  The Act also requires all trials supporting FDA-approved drugs be registered when the trials are initiated and that all such outcomes be posted within one year of drug approval on the U.S. National Institutes of Health's (NIH) clinical trials Website.

H.R. 3580, known as the FDA Amendments Act of 2007, was signed into law October 1st and is meant to ensure that FDA staff have the additional resources needed to conduct the complex and comprehensive reviews necessary to new drugs and devices.  The amendments represent the most comprehensive overhaul of food and drug law since 1997 and include several major changes to the Federal Food, Drug, and Cosmetic Act (“FDCA”), including the reauthorization, increase, and addition of new user fees for prescription drug and device products for another five years; an increase of the FDA’s regulatory authority to monitor the safety of marketed drug products and medical devices; the addition of incentives for development and oversight of pediatric drugs and devices; and strengthening of food safety requirements.


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