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Animal Ethics Biosafety Human Research Ethics Research Integrity

(US) Clinical trial coordinators sentenced to prison after data falsification scheme – Endpoints News (Paul Schloesser | October 2022)

Posted by Connar Allen in Human Research Ethics on December 3, 2022
Keywords: Clinical trial, International, Medical research, Merit and integrity, Protection for participants

The Linked Original Item was Posted On October 19, 2022

A sepia silhouette cartoon of a man stricken holding his hands in a prison cell.

After two Florida-based CRO study coordinators pled guilty to falsifying clinical trial data, the DOJ said Wednesday that those two have been sentenced to more than two years in prison each.

Falsifying clinical trial data and results is not a victimless crime.  At one level, it is potentially fraud of a funding body or institution.  On another, it can place future patients and the wider community at risk, because of a faulty understanding of a condition or the effectiveness/safety of an experimental intervention.  It seems this US court agrees.  An additional factor when someone considers falsification is that, if you believe in the promise of an intervention, if you cheat, you might sully the reputation of the intervention far into the future.

Federal judge Donald Graham sentenced Analay Rico, lead study coordinator at Tellus Clinical Research, to 40 months in prison, and Daylen Diaz, assistant study coordinator and research assistant at Tellus, to 24 months in prison, along with $2.1 million in fines related to their conspiracy to commit fraud.

Tellus, which has worked with big-name pharma sponsors in the past like Pfizer, Gilead, Takeda, Boehringer Ingelheim and Eli Lilly, initially came under scrutiny for two trials related to opioid dependency, two for irritable bowel syndrome, and one for diabetes.

According to the indictment filed in March 2021, Diaz and Rico entered false information in the case histories of subjects to make it appear as if the subjects were eligible for a trial, or they recruited patients into trials who were not eligible, and obtained personally identifiable information from third parties to enroll patients without their knowledge or consent.

Three others affiliated with Tellus have previously pled guilty and are currently in prison after the scheme was uncovered.

Clinical trial coordinators sentenced to prison after data falsification scheme
After two Florida-based CRO study coordinators pled guilty to falsifying clinical trial data, the DOJ said Wednesday that those two have been sentenced to more than two years in prison each. Federal judge Donald Graham sentenced Analay Rico, lead study coordinator at Tellus Clinical Research, to 40…

Related Reading

The Dark Side of Research: Scientific Fraud – Davidson Institute (Jonathan Berkheim | September 2022)

(US) Clinical Researchers Sentenced in Connection with Scheme to Falsify Drug Trial Data – The Office of the Attorney General blog (August 2021)

(EU) How can institutions and funders help to police questionable research practices? – Nature Index (Dalmeet Singh Chawla | September 2021)

(US) Miami doctor pleads guilty to falsifying clinical trial data for asthma medication – Miami Herald (Jay Weaver | January 2021)

Continued post-retraction citation of a fraudulent clinical trial report, 11 years after it was retracted for falsifying data (Papers: Jodi Schneider, et al | October 2020)

(Taiwan) Researcher formerly of OSU and Taiwan’s Academia Sinica gets 10-year ban – Retraction Watch (Adam Marcus | February 2020)

How Universities Cover Up Scientific Fraud – Areo (Justin T Pickett | February 2020)

Fraud In A Leading UK Scientist’s Lab – BuzzFeed News (Peter Aldhous | July 2019)

(Japan) Researcher at Japan stem cell institute falsified nearly all images in 2017 paper – Retraction Watch (Victoria Stern | January 2019)

(US) Mount Sinai multiple sclerosis researcher admits to misconduct – Retraction Watch (Ivan Oransky | May 2018)

Ohio State just released a 75-page report finding misconduct by a cancer researcher. What can we learn? – Retraction Watch (Ivan Oransky | March 2018)

Why do researchers commit misconduct? A new preprint offers some clues – Retraction Watch (Ivan Oransky | April 2017)

How many scientists fabricate and falsify research? A systematic review and meta-analysis of survey data (Papers: Daniele Fanelli | 2009)

Academic misconduct claims: Fresh call for national body – The Australian (Darragh O’Keefe | October 2016)

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