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Animal Ethics Biosafety Human Research Ethics Research Integrity

(US) Data Corruption: DOJ Targets Fraud In Medical Research Trial In The Era Of COVID-19 – JDSUPRA (Jessica Heim, et al | March 2021)

Posted by Dr Gary Allen in Human Research Ethics, Research Integrity on April 4, 2021
Keywords: Clinical trial, Data management, Medical research, Research integrity, Research Misconduct, Research results, Researcher responsibilities

The Linked Original Item was Posted On March 23, 2021

The word "FRAUD" lifted and coloured amongst words relating to its investigation

In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major concern” for DOJ going into 2020.1 Recent remarks from Deputy Attorney General Daniel Feith, coupled with several recent criminal prosecutions, suggest that increased enforcement relating to misconduct in clinical research trials will be a new focus of DOJ enforcement.

Even outside of a global pandemic, fraud in a clinical trial could cause dire, if not fatal, consequences.  At the very least they could see the public receiving treatment that isn’t efficacious.  COVID19 has made the stakes much higher and the consequences global.  The efforts of the US DOJ should be publicly acknowledged.  We have included links to seven related items.

Background: Clinical Research Trials are a Pivotal Part of the FDA’s Drug-Approval Process

To obtain Food and Drug Administration (“FDA”) approval for new drugs and medical devices, manufacturers — also known as “sponsors” — must prove that a proposed new product is safe for human consumption or use. To do so, sponsors conduct clinical trials that test the product on human beings, and submit data from such trials to the FDA.2 After obtaining the FDA’s go-ahead to begin clinical trials, sponsors typically hire (either directly or indirectly via contract research organizations) individual research laboratories known as “investigators” to actually conduct the trials. In entering into this agreement, investigators must agree to comply with all FDA regulations.3 However, the sponsor is responsible at all times for monitoring clinical investigations and must ensure their investigators’ compliance.4 Ultimately, data from clinical research trials becomes a key component of a sponsor’s final application for FDA approval of its new drug. False or misleading statements in any part of a final application (including clinical research data) can be grounds for the FDA withholding or withdrawing its approval of a new drug, and can also be the basis for civil and criminal enforcement actions against the sponsor, contract research organization, or investigator.5

A Major Concern: the DOJ’s Enforcement of Clinical Trial Fraud

Clinical trial fraud cases typically begin with an investigation by the FDA’s Office of Criminal Investigations, and are ultimately prosecuted by the DOJ — usually the CPB or the Health Care Fraud Unit.6 These investigations are complex and typically take years before reaching a conclusion. Historically, however, there have not been many prosecutions for misconduct regarding clinical research data.

1 Gustav Eyler, Dir. Consumer Prot. Branch, Dep’t of Justice, Remarks at the Food and Drug Law Institute’s Advertising and Promotion Conference (Oct. 18, 2019).

2 21 C.F.R. §§ 312.20–312.23.

3 Food & Drug Admin., Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs (May 2010).

4 21 C.F.R. § 312.56.

5 21. C.F.R. § 314.150; 21 U.S.C. § 331(jj) (authorizing civil penalties); 18 U.S.C. § 1001(a)(2) (criminal liability for false statements to government officials); 18 U.S.C. §§ 1341, 1343 (criminal mail and wire fraud); 21 U.S.C. § 331 (failure to establish and maintain accurate clinical records); 18 U.S.C. § 1347 (health care fraud).

Data Corruption: DOJ Targets Fraud In Medical Research Trial In The Era Of COVID-19 | JD Supra
In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in...

Related Reading

(US) How claims of voter fraud were supercharged by bad science – MIT Technology Review (Spenser Mestel | November 2020)

Spike in research misconduct feared after Covid disruption – Times Higher Education (Jack Grove | August 2020)

Covid-19 Research Scandals Illustrate What’s Wrong With Science – Elemental (Dana G Smith | August 2020)

Despite its big COVID moment, science is in crisis – Crickey (Stephen Bartos | August 2020)

The Science Sleuth Holding Fraudulent Research Accountable – leapsmag (Kira Peikoff | August 2020)

‘Fraud and Misconduct in Research’ – Inside Higher Ed (Nick Roll | December 2017)

(Australia) Fake science: Taxpayers shell out more than $3 million for unreliable research – SMH (Timna Jacks | April 2017)

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