What Do You Do With a Negative Drug Study? Throw it Out?

Many drug studies are never published, demonstrating publication bias and presenting the risk that the public is not being fully informed.

Publication bias refers to the tendency for studies to be published based on “the direction or strength of the study finding” or whether the study got the hoped for result. Several reviews have found that drug studies with positive results are more likely to be published than studies with negative results. This finding “means the dissemination of research findings is a biased process.”

The publication of positive studies and suppression of negative studies means that drugs might get approved or prescribed based on misleading reporting: Under-reporting due to publication bias leads to “the overestimation of efficacy and the underestimation of safety risks (Trials. 2010 Apr 13:11:37).” “Publication bias threatens the practice of evidence-based medicine . . .. and puts patients at risk.”

Between 1999 and 2007, less than half of registered and completed studies were published (PLoS Med. 2009 Sep;6(9):e1000144).

A new study of 6,720 studies conducted in Canada found that only 55% had their findings published, and 32% never made their results available to the public in any form.

This phenomenon is not unique to Canada. Only 39% of clinical trials conducted in German universities between 2009 and 2013 were published within 2 years of completion.

This important study suggests that there is still a serious problem with the process of approving drugs and accurately informing the public.

FACETS. 23 November 2023;doi.org/10.1139/facets-2022-0208.

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