We have been publishing articles on the bioethical implications of breaching the laws that establish a maximum period for reporting results to clinical trial registers, in both Europe and the United States. For several reasons—we believe all unjustified— new potentially vital findings in the medical field are not immediately available to eventual patients who may need them. In the last article, we cited two therapies discovered and delayed in critical fields.
Our two previous articles (read HERE and HERE) also underlined the comments of specialists referring to the responsibilities of the competent authorities and their weak position, as well as the lack of understanding of universities, sponsors, and researchers themselves of the importance of posting their findings.
Now, an article discussing the ruling has been published in the journal Nature (February 26, 2020), entitled “Missing clinical trial data must be made public, [United States] federal judge says”. Below are some of the more relevant points.
“Drug companies, device manufacturers, and universities must turn over missing data from hundreds of clinical trials conducted in the United States from 2007–17, a federal judge ruled this week. The ruling from the Southern District of New York says government agencies including the National Institutes of Health, the U.S. Department of Health and Human Services, and the Food and Drug Administration (FDA) for years misinterpreted a law requiring them to collect and post data to ClinicalTrials.gov, a publicly accessible government database.” read more HERE.
Our Observatory supports the American federal ruling and hopes that European countries will soon follow suit.