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In this issue of JAMA Internal Medicine, we publish a report1 that highlights an important area for improved public reporting of clinical trials and enhanced transparency at the US Food and Drug Administration (FDA). Seife1 identifies numerous instances in which the FDA found evidence of apparent research misconduct serious enough to warrant regulatory action at clinical trial sites, but mention of these problems was largely missing from articles in medical journals. The specific examples cited by Seife1 are disturbing: a foot amputation 2 weeks after a stem cell procedure, although the published trial states that all patients were aware of “major clinical improvements in the treated (more ischemic) leg”; an entire study deemed unreliable by the FDA but published without mention of the issue; a falsification of documents in a number of trials, in part because the falsifications led to the death of a subject in a chemotherapy trial (the researcher pled guilty to fraud and criminally negligent homicide); and a claim of a mortality benefit for a drug that included data from a trial site where patient records were allegedly altered.
Steinbrook R, Redberg RF. Reporting Research Misconduct in the Medical Literature. JAMA Intern Med. 2015;175(4):492-493. doi:10.1001/jamainternmed.2014.8052