Stanford, UPenn, Other Institutions Breaking the Law, Putting Patients At Serious Risk

Several medical research institutions have been violating a 2007 federal law which requires them to report findings of human clinical trials to ClinicalTrials.gov within one year of completing the study.

[DIGEST: STAT News; Advisory Board Company; The Verge]

Stanford, the University of Pennsylvania, University of Pittsburg, Memorial Sloan Kettering Center and other top medical research institutions are breaking the law and putting patients at serious risk, according to an investigation by STAT News. But the government is doing almost nothing to enforce it.

Second Nexus
Credit: Source.

A federal law requires medical research conducting human clinical trials to report study results on the safety and benefits of medical treatments within a year of completing a study. Congress passed the law to ensure that findings from human drug and medical device tests were available on the National Institute of Health’s website, ClinicalTrials.gov, to prevent companies from hiding data that would hurt pharmaceutical sales. But many if not most institutions have ignored this requirement, submitting 95 percent of results either after the deadline or not at all.  This has left doctors and patients without essential information about potential dangerous side effects of medical treatments.

Late reports have real world consequences. For example, a University of Indiana researcher studying Avastin, a controversial treatment for breast cancer, failed to report that the drug was so harmful that the trial was canceled prior to completion. Doctors could have benefitted from that information, but the data was not made public; several years later the FDA

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