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Results Needed

The US Food and Drug Administration has cited a clinical trial sponsor for not depositing its results at ClinicalTrials.gov, Science reports. It adds that this appears to be the first time FDA has reprimanded a company for not posting results.

As Science notes, the US has required since 2007 that sponsors of clinical trials report their results. Even so, many clinical trial results went unreported, as a 2014 study in PLOS One found that about 30 percent of clinical trial results were not reported within four years and as Pharmalot's Ed Silverman reported at Stat News in 2016 that results from about half the results from clinical trials conducted by large drug makers in the previous 10 years had not been released.

The National Institutes of Health clarified its rules for reporting results, which went into effect in 2017, to require that the design and result of clinical trials must be disclosed. Despite that, some trial sponsors have been slow to report their findings and Vox suggested that this lack of reporting appeared to be tolerated by federal agencies.

But Science now reports that the FDA has cited the firm Acceleron for not providing data from its trial of a kidney cancer therapy. In its notice of noncompliance, FDA has given the company 30 days to report its results before facing fines.

Acceleron tells Science that it ceased development of the drug following the trial's disappointing results, and that it will provide the missing data.

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