Will the FDA Crack Down on Clinical Trial Reporting Noncompliance?

The FDA has issued its first notice of noncompliance to Acceleron Pharma for failing to submit clinical trial results to ClinicalTrials.gov, the federal government’s database of privately and publicly funded clinical studies. If the pharmaceutical company does not submit the required data within 30 days, the agency is authorized to seek civil monetary penalties.

In the notice, the FDA stated that Acceleron failed to submit safety and efficacy data from its phase II trial of dalantercept in combination with axitinib for the treatment of patients with advanced renal cell carcinoma.

Reporting of clinical trial results has been a recent focus of the regulatory agency. An investigation published in Science in January 2020 found that, while the U.S. government requires companies, universities, and other institutions that conduct clinical trials to record results in a federal database, many fail to comply – and federal officials have previously done little to enforce the law.

In its statement, the agency also announced that it sent more than 40 prenotices of noncompliance to clinical trial sponsors to encourage voluntary compliance with the reporting requirements.

“The FDA takes its role in enforcing the ClinicalTrials.gov registration and results information submission requirements extremely seriously and we will continue to encourage voluntary compliance with these requirements,” the FDA said in a statement. “When necessary, the FDA will take appropriate actions to help ensure that required information is available on ClinicalTrials.gov as required by law and for the benefit of clinical trial participants and public health.”

Source: FDA statement, April 28, 2021.