CFDA Taking Action on Clinical Trial Fraud

On August 24, 2016 the CFDA published a notice on clinical trial fraud. The eight clauses of the notice define clinical trial fraud, explain how responsibility is apportioned, give opportunities for offenders to withdraw fraudulent data, and lay out the consequences for those who persist in the use of fraudulent data. Some specific examples given of data fraud include fabricating patient outcomes, concealing or altering adverse event records, selectively reporting data, and destroying data. The company registering the product for which the fraudulent clinical trial was used bears total responsibility. In addition, CROs or other organizations involved in the trial would be responsible for fraud in the specific areas of the trial that they worked on. This notice goes along with a CFDA release from August 15, 2016 where the agency said that it would work alongside legal authorities to make clinical trial fraud a legal offense. As a result of the CFDA’s campaign against clinical trial fraud, about 80% of companies using clinical data for their product registrations have pulled back their submission from the CFDA.