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Fake data in Clinical Trials
Manage episode 454813723 series 3506216
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Florida medical clinic owner and staff were charged with falsifying clinical trial data. According to the indictment, from September 2015 to March 2018, the defendants at AMB Research Center in Miami fabricated clinical trial data for profit. They knowingly enrolled subjects who did not meet eligibility criteria, falsified lab data and medical records, and falsely represented that subjects were taking the studied drug when they were not.
Co-owners Montalvo and Garmendia, were charged, along with Portela, a pharmacy technician at the research center. This case serves as a reminder that the FDA and DOJ do not overlook past misconduct, emphasizing that even those who are not principal investigators can face legal repercussions. The focus on clinical trial fraud remains a significant concern, with the DOJ highlighting it as one of their key enforcement pillars.
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