What exactly are clinical researchers doing to merit this scrutiny? And what can academic medical centers and other universities and hospitals do to protect themselves against the misconduct of their researchers?
What DOJ is Investigating
There are a number of things related to clinical research that can draw the attention and ire of the Justice Department.
First and foremost, according to public statements by DOJ officials, clinical trial fraud is a top priority of DOJ’s consumer protection branch. Some of the clinical trial fraud that DOJ is pursuing is straightforward, while other types are more nuanced.
For an example of straightforward clinical trial fraud, in September of 2022, three Florida medical clinic owners were indicted for allegedly fabricating clinical trial data in at least four ways: by (1) enrolling subjects in the trial who the defendants knew did not meet eligibility criteria, (2) falsifying laboratory results, (3) falsifying medical records, and (4) falsely representing that subjects were taking the drug being studied when, in fact, they were not.[2] The indictment alleges that these defendants did all of this to boost profits from the clinical trial.
But nuanced types of fraud are being brought by DOJ as well. For example, a CEO of a biotech company went to trial and was convicted of disseminating misleading information about the efficacy of a particular drug. According to DOJ, the CEO announced that the drug’s clinical trial saw results that the...
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