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Clinical trial registration, reporting, publication and FDAAA compliance

A new study published in BMJ Open found that for 15 drugs approved by the US Food and Drug Administration (FDA) in 2012, a median 57% of clinical trials were registered, and only 65% of trial results were publicly available. Almost half of the drugs had at least one undisclosed phase II or III trial. For the drug trials required by law to publicly report results, only two-thirds (67%) actually did.

However, PhRMA have published a blog refuting the findings. In this blog, PhRMA state that “…the authors provide inaccurate and misleading information about industry compliance with legal and ethical principles, which appears to stem from a fundamental misunderstanding of those requirements. Following are several areas in which the Miller study is contributing to misinformation about the clinical trial process and data sharing…”. The blog then goes on to provide a number of reasons for why the paper published in BMJ Open is inaccurate.

The PhRMA blog concludes by stating: “PhRMA and its members agree with the authors that enhancing public health through responsible clinical trials data sharing is critically important. However, it is not in the best interest of public health to spread misinformation and create distrust.”.



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