This CRO "rolled over" several times: Falsified clinical trial data was sent to prison by the FDA

Recently, two clinical researchers in the United States were sentenced to 46 months and 30 months imprisonment and fined $2.

In this case, both 52-year-old Eduardo Navarro and 50-year-old Nayade Varona are staff members of Tellus Clinical Research

According to court documents, they admitted that they had jointly falsified the data of two clinical trials with others.

01 "Repetitious Offender" Tellus

Tellus is a clinical research organization that has worked with well-known pharmaceutical companies such as Pfizer, Gilead, Takeda, Boehringer Ingelheim and Eli Lilly

At the same time, this clinical trial data falsification issue is not the first time Tellus has been accused

The indictment shows that from at least February 2014 to July 2016, the four defendants fabricated clinical trial data for profit while working at the Tellus clinical research institution

Catherine A.

Brian M.

"Falsifying clinical data is an act that violates public trust and endangers the safety of consumers

In the Navarro and Varona clinical trial data falsification case, the FDA Criminal Investigation Office is responsible for investigating the case; trial lawyers Lauren Elfner and Joshua Rothman of the Consumer Protection Division of the Civil Court are responsible for the case.

02 Increasingly strict FDA

In recent years, the FDA has become more stringent in its management of clinical trial data

In the past ten years, in the United Kingdom and Europe, pharmaceutical companies have often delayed or concealed trial data, causing public concerns about the safety of approved drugs

When data was postponed or concealed, or even submission of false data became a trend, in July last year, the FDA issued guidelines for the finalization of Section 801 of the FDA Amendment Act (FDAAA): For unregistered research, it will not be reported.

After the release of the finalized guidelines, some applicants still failed to comply with the requirements of the guidelines

When most people thought that this was another "thunder and rain" regulation, the FDA finally started to take action in April this year

On April 28, the FDA issued a non-compliance notice to Acceleron Pharma, the sponsor who failed to submit the necessary information for clinical trials to the federal registration agency, and warned that it may face fines

The FDA said that as early as July last year, it had issued a warning letter to Acceleron for failing to submit the results of the Phase II trial of the Dalantercept drug in the treatment of advanced renal cell carcinoma, but Acceleron has not made corrections
.
The FDA pointed out that Acceleron must publish the data before May 27, otherwise it will face civil fines of up to $10,000 a day or other regulatory actions, including injunctions or criminal proceedings
.

After receiving the notification, Acceleron said that after the test results did not meet expectations, the company had stopped the development of the drug in 2017
.
However, it will still comply with FDA's requirements and publish clinical trial results on ClinicalTrials.
gov within the prescribed 30-day remedial period
.

Then, in July of this year, the FDA issued a second non-compliance notice
.
According to the FDA, the pharmaceutical company Accuitis failed to submit clinical trial results to the federal registration agency in accordance with the requirements of federal regulations in the clinical trial of using ACU-D1 to treat rosacea.
Submit all required result information"
.
But it is clear that Accuitis has not complied with FDA requirements
.

The FDA pointed out in the non-compliance notice that Accuitis must publish data within 30 days, otherwise it will face civil fines of up to $10,000 per day or other regulatory actions
.

Jan Hewett, a regulatory consultant at the FDA Center, said: “Although the FDA hopes that applicants will voluntarily comply with the regulations, it also hopes that the supervised party understands the importance of compliance and the potential adverse effects on drug research and evaluation caused by non-compliance.

.
"

For the supervision of clinical trial data, China's Food and Drug Administration has also adopted thunder means
.

On July 22, 2015, the State Food and Drug Administration issued the "Announcement on Carrying out Self-inspection and Verification of Drug Clinical Trial Data (2015 No.
117)", according to "the most rigorous standards, the most stringent supervision, the most stringent The penalties and the most serious accountability are required to ensure the safety of the people’s diet and medication.
1,622 drug registration applications that have been declared for production or import are subject to drug clinical trial data verification, and if there are any problems, they will be automatically withdrawn
.
For applications that are not submitted or withdrawn within the specified time, the General Administration will conduct unannounced inspections
.
Once problems are found, companies will face strict penalties such as "not accepting their applications within 3 years", "revocation of the qualifications of drug clinical trial institutions", and "blacklisting"
.

At that time, more than 800 pharmaceutical companies were facing the test of "withdrawal or not"
.
After feeling that the content of the announcement was not just talking, a large number of companies withdrew their registration applications
.
This incident is also called the "722 Massacre" by the medical community
.

What was the quality of clinical trial data in China at that time? When I saw that the companies that had not withdrawn their applications were almost foreign companies, I had the answer
.
The strict supervision of the "722 Massacre" also laid an important foundation for the quality of subsequent clinical trial data
.

The safety of medicine is undoubtedly the most important product as a product for curing diseases and saving lives
.
The safety of drugs requires strict law enforcement by regulators, but the most fundamental thing is the strict self-requirements and honesty and trustworthiness of pharmaceutical companies
.