The degree to which the results of clinical trials are not reported – especially when the expected results aren’t found – is a serious problem. It’s inefficient, because down the road another researcher may seek to do the same test, not realising that it has already been unsuccessfully tested. It is dangerous, because researchers and clinicians may expose patients to an agent because they don’t know about the failure.
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Now, potentially hundreds of universities, drug companies, and medical device manufacturers are on the hook to release previously unpublished data. The ruling affects trials conducted for as-yet-unapproved drugs and devices in that 10-year stretch, according to a lawyer for the plaintiffs — meaning hundreds or even upwards of 1,000 noncompliant trials would be forced to post data.
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The ruling, from a federal judge in New York’s Southern District, puts sponsors of clinical trials during that span out of compliance if they have not posted results to the government repository ClinicalTrials.Gov.
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“This decision brings us one step closer to what federal law requires — providing the American public with complete access to clinical trial results on drugs and medical devices approved by the FDA,” said Christopher Morten, a supervising attorney at New York University’s Law & Policy Clinic who represented the plaintiffs. The ruling, he said, “makes it harder for drug companies, device manufacturers, and other trial sponsors to keep unfavorable trial results secret.”
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