A federal judge in the US state of Florida sentenced Eduardo Navarro and Nayade Varona, both former employees of Tellus Clinical Research in Miami, to prison for falsifying clinical trial data for a drug being tested against irritable bowel syndrome. Navarro will serve 46 months in prison and Varona 30 months. Both pleaded guilty to the crimes. Judge Jos\u00e9 Martinez also ordered the defendants to pay a fine of US$2 million. The case was investigated by the office of criminal investigations at the Food and Drug Administration (FDA). Another four people have been charged, including Martin Valdes, the doctor who owns Tellus.<\/p>\n
Between February 2014 and July 2016, the pair enrolled ineligible patients in clinical trials, falsified laboratory results and medical records, and stated that some individuals were taking the drug when this was not true. “Falsifying clinical trial data puts the public\u2019s health at risk,\u201d said Acting U.S. Attorney Juan Antonio Gonzalez for the Southern District of Florida, according to the U.S. Department of Justice\u2019s website. \u201cCompromised clinical data jeopardizes the researchers\u2019 ability to evaluate the safety and efficacy of new drugs. Prosecuting these cases will continue to be a top priority for our office.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"A federal judge in the US state of Florida sentenced Eduardo Navarro and Nayade Varona to prison for falsifying clinical trial data for a drug being tested against irritable bowel syndrome","protected":false},"author":475,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[155],"tags":[230],"coauthors":[785],"class_list":["post-417623","post","type-post","status-publish","format-standard","hentry","category-good-practices","tag-ethics"],"acf":[],"_links":{"self":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/417623","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/users\/475"}],"replies":[{"embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/comments?post=417623"}],"version-history":[{"count":2,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/417623\/revisions"}],"predecessor-version":[{"id":418229,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/417623\/revisions\/418229"}],"wp:attachment":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/media?parent=417623"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/categories?post=417623"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/tags?post=417623"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/coauthors?post=417623"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}