More than half of US drug safety studies never see the light of day

Only 43% of the evidence of safety and efficacy that the US Food and Drug Administration uses to approve drugs is published in scientific journals. The authors of the survey say this amounts to “scientific misconduct”

The results of more than half of all clinical trials that demonstrate the safety and effectiveness of new drugs are not published within five years of the drug going on the market, according to an analysis of 90 drugs approved by US regulators between 1998 and 2000.

The researchers, who traced the publication or otherwise of 909 separate clinical trials in the scientific literature, wrote that the failure of drug companies to publish the evidence relating to new medicines amounted to “scientific misconduct”. They said it “harms the public good” by preventing informed decisions by doctors and patients about new medicines and by hampering future scientific work.

The team also found evidence for a “publication bias”. Trials with statistically significant results were more likely to be published than those with non-significant results, as were those with larger sample sizes.

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