China's regulatory authority is challenging reports that 83% of trials have fabricated results, but the numbers still suggest the country has a big data-integrity problem.
Last year, the China Food and Drug Administration (CFDA) ordered companies behind 1,622 regulatory applications for new drugs--mainly generics--to carry out "self-examination on the authenticity, integrity and compliance of clinical trial data." The idea was to give them an opportunity to withdraw problematic filings and reapply after they'd ironed out problems with their data.
In June, reports showed that companies had pulled 1,193 applications, which led to "reports in some media that '80% of China’s clinical trial data are fraudulent'," according to a CFDA official, who insisted that those assertions "are not fact-based."
Some applications may have been yanked because of deliberate data fraud, the unnamed official said in a statement. But some may have been withdrawn for other reasons, the official insisted, citing problems that, while severe, don't constitute fakery.
For instance, some studies may not have complied with Good Clinical Practice (GCP), while others could have had incomplete data or failed to "demonstrate the safety and effectiveness for the drug in application," the statement said.
According to the CFDA numbers, 193 of the marketing applications were for products exempted from clinical trials, leaving 1,429 applications under scrutiny. The CFDA has been investigating the applications and--as of the end of September--said 117 had been verified and 30 rejected "due to defects with authenticity."
The CFDA says that accounts for about 2% of the total number of registration applications selected for self-examination and verification so far. When the audit was announced earlier this year, some industry observers said they believed up to half of all marketing applications in China could include forged data.
All told, "27 applications, as well as 11 clinical trial institutions and the [contract research organizations] suspected of providing fraudulent data have been investigated," the regulator's latest statement said.
Either way, it seems the self-examination exercise has revealed serious issues with clinical research in China. Even if the investigation reveals that deliberate falsification occurred in a minority of cases, the high rate of voluntary withdrawals is evidence that substandard clinical testing is a massive issue.
For its part, the CFDA said the self-audit program and crackdown on data fraud "aims at encouraging innovation and creating a favorable environment for fair competition in order to ensure the safety and effectiveness of the drug approved to the market."
CFDA director Bi Jingquan recently described falsified clinical data as a "cancer" on the development of Chinese-made medicines that threatened to undermine the credibility of the domestic drug industry.
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