Intended for healthcare professionals


Ten years of clinical trial data cannot legally be hidden from the public, US court rules

BMJ 2020; 368 doi: (Published 02 March 2020) Cite this as: BMJ 2020;368:m832
  1. Owen Dyer
  1. Montreal, Canada

US public health watchdogs have been failing for years in their legal duty to inform the public about the results of clinical trials, a federal court has found.

The US district court for southern New York ruled that an exemption granted by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) that allowed hundreds of studies to escape reporting requirements laid down by Congress was unlawful.1

Transparency advocates hailed the ruling but expressed concern that its impact could be limited, as the court said it lacked the power to compel the FDA and NIH to enforce existing laws on disclosure of trial results, which to date they have been reluctant to do.

Legislation passed in 1997 required the government to set up the website, to promulgate results from clinical trials of products approved to treat serious diseases. But with no …

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