Data Integrity ‘More Than Just A GMP Issue’ As Attention To Clinical, Nonclinical Lapses Grows
Sponsors should notify US FDA quickly when they detect data quality issues in preclinical and clinical research, particularly for applications under review, experts say in a rebuke to Novartis’ delayed notification about Zolgensma data manipulation.
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Submission of manipulated clinical data to support product approval is a ‘major concern’ for the DoJ, consumer protection branch director Gusav Eyler says, adding that some of the problems relate to outsourcing of trials. Also, DoJ and HHS OIG are using data analytics to identify outliers in prescribing and reimbursement claims.
Data Manipulation Not Common, But Happens "More Than I Would Have Expected," US FDA's Sharpless Says
As fallout from the Novartis Zolgensma data manipulation incident continues, US FDA acting commissioner Norman Sharpless notes that "at some level we have to trust the sponsors."
Novartis CEO Explains Delay In Telling US FDA About Zolgensma Data Fraud: We Wanted To Understand It First
Novartis is in the process of "exiting" the "small number" of scientists involved in the fraud, CEO Narasimhan says.