A new study published in PLoS Medicine suggests that more than half the clinical trials to support drug approval remain unpublished 5 years or more after FDA approval. The journal editors summarize:
"(These findings) also reveal selective reporting of results. For example, they show that a pivotal trial in which the new drug does no better than an old drug is less likely to be published than one where the new drug is more effective, a publication bias that could establish an inappropriately favorable record for the new drug in the medical literature. Importantly, these findings provide a baseline for monitoring the effects of the FDA Amendments Act 2007, which was introduced to improve the accuracy and completeness of drug trial reporting. Under this Act, all trials supporting FDA-approved drugs must be registered when they start, and the summary results of all the outcomes declared at trial registration as well as specific details about the trial protocol must be publicly posted within a year of drug approval on the US National Institutes of Health clinical trials site."
Maggie Mahar blogs about the news of this study, offering some additional perspectives.
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