New study finds publication bias among trials submitted to FDA
Tuesday, November 25, 2008 - 17:56
in Health & Medicine
A quarter of drug trials submitted in support of new drug applications to the US Food and Drug Administration (FDA) remain unpublished five years after the fact, says new research published in the open access journal PLoS Medicine. Among those trials published, unexplained discrepancies between the FDA submissions and their corresponding publications - the addition or deletion of outcomes, changes in the statistical significance of reported outcomes, and changes in overall trial conclusions - tended to lead to more favourable presentations of the drugs in the medical literature available to health care professionals...