FDA expands the list of targets for violations for the first time: researchers who fail to report clinical trial results on time will be punished

The FDA's supervision of clinical trials has become increasingly strict
.

Globally, the promotion of transparency in clinical trials has always been a long-standing problem.
Well-documented and transparent data helps people understand how drugs work, and it also helps to replicate the results of trials
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Similarly, disappointing clinical trial results should no longer be concealed or ashamed to show others

Beginning in 2016, the United States has tightened regulations on the transparency of clinical trials, requiring researchers to fully disclose the design and results of clinical trials, regardless of whether they are successful or not
.

Since the beginning of this year, the FDA has even begun to take action, issuing fines to two companies one after another for violations

Recently, the FDA warned for the first time that it would impose a fine on the PI of a clinical trial because it failed to submit the research results as required by the federal law as scheduled
.

This is also the first time the FDA has expanded the list of targets for violations from companies to individuals

01 PI was warned

01 PI was warned

On August 31, the FDA issued a warning letter to Los Angeles surgeon Andrey Petrikovets, stating that the doctor conducted a study at the University Hospital of Cleveland Medical Center affiliated to Case Western Reserve University and the results were announced.
The deadline was exceeded
.

This is a study of different pain solutions after vaginal and pelvic floor reconstruction surgery.
It was completed in June 2018.
According to federal law, one year after the completion of the study, the results should be published in the database
.

In July last year, the FDA wrote to Petrikovets, informing it that it had not released the results
.

The other party replied in January this year and was busy with the new crown epidemic

According to the requirements of federal law, relevant responsible parties need to submit registration and summary result information to the ClinicalTrials.
gov database for certain applicable clinical trials
.

Those who submit certain applications or materials to the FDA must also prove that the applicable clinical trials cited in these applications or materials meet the requirements

These violations include failure to submit the required clinical trial information, and submission of false or misleading clinical trial information
.

The FDA also has the right to evaluate the civil fines for these violations.
If the responsible party fails to take appropriate corrective measures within 30 days of receiving the notification of not submitting the required information, the responsible party may be subject to additional civil fines
.

In July last year, the FDA issued guidelines for finalizing Section 801 of the FDA Amendment Act (FDAAA): For all violations found in a single procedure, the maximum fine is no more than $10,000
.

If the sponsor fails to correct the violation within 30 days after receiving the notification of such violation, a fine of not more than 10,000 U.

02 Has long been "moving knife" to the enterprise

02 Has long been "moving knife" to the enterprise

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

According to Trials Tracker data, about 28% of the results of nearly 9,900 clinical trials have not been reported to ClinicalTrials.

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
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This is the first non-compliance notice issued since the FDA issued the finalized guidelines, and it is considered the first time that fines have been taken to respond to the public's request for transparency in clinical research

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 Dalantercept for 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 Register in accordance with the requirements of federal regulations in the clinical trial of using ACU-D1 for the treatment of 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.

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