The five-plus years of Cetero Research clinical data called into question by the U.S. Food and Drug Administration is being shortened by nearly nine months.
The FDA in July disclosed an inquiry into the Cary, North Carolina clinical research organization that alleged Cetero workers falsified clinical trial documents and test results from April 1, 2005 to June 15, 2010. The agency in July said that pharmaceutical companies who had clinical work done by the CRO within that time frame may need to repeat the trials. Companies were urged to at least confirm the data.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
The FDA said the new time frame for studies “with data integrity concerns” runs from April 1, 2005 to Aug. 31, 2009, according to an Oct. 26 update. The FDA is notifying pharmaceutical companies of the change.
“The agency will now accept studies conducted after Sept. 1, 2009 for submission and review by the agency without reanalysis, repeating or further audit by Cetero, or a third party,” the FDA said. “This is based on additional information recently collected by FDA and provided by Cetero.”
Cetero focuses on early phase clinical research. Only work done at Cetero’s Houston site has come under scrutiny. The FDA said an investigation found time and date discrepancies regarding when Cetero staff was working and when test samples were studied. While Cetero attributed the discrepancies to workers trying to claim overtime, the FDA said Cetero’s reasoning doesn’t explain why weekday records were falsified. The FDA also found falsified data from multiple studies for multiple pharmaceutical sponsors.
In the Oct. 26 update, the FDA said the Sept. 1, 2009 cutoff date was selected because the additional information collected by the agency and provided by Cetero demonstrate that the company “implemented appropriate procedures following this date.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The FDA did not say how many pharmaceutical companies or how much data was affected or called into question. But the agency reiterated that it is unlikely that the concerns affect the safety and efficacy of drugs that are already on the market. Notification of drug companies, the FDA said, was a “precautionary measure.”
