Should FDA Accept Data From Clinical Trials Conducted in China?    
​[Posted on: Thursday, September 29, 2016]

This week the Chinese FDA announced results of its year-long investigation into clinical trials conducted in China, and the results were appalling. But its impact on Chinese manufactured drugs sold in the US is likely minimal, at least in the near future. Chinese auditors found that more than 80% of clinical trials contained fabricated and fraudulent data, omission of adverse events, incomplete or missing source documents, and many other egregious findings. The auditors observed that fraud in the data started with preclinical studies, and was even worse for the generic drugs where about 90% of the times, the generic drug did not show bioequivalence to the reference drug but data was fabricated to make it look otherwise. Approval of about 1200 drugs was withdrawn by the Chinese FDA based on this investigation. The report also commented that similar findings in US and Europe would lead to blacklisting of the involved personnel and severe penalties. It is not clear from the report if any punitive actions were taken against the responsible parties. Before we start getting worried about the US supply chain, there a few important points to note. These drugs were all available in the Chinese market; there is no indication that these same drugs were also available on the US or EU markets. The Chinese regulators did not list the drugs whose approval was withdrawn, or the clinical trials found to be fraudulent. The number of at fault trials is so high that one can assume that practically all trials were defective and practically every clinical trial personnel was involved. This raises grave concerns about FDA acceptance of data from clinical trials conducted in China in support of INDs and NDAs. However, FDA also has audited clinical trial data from China and not found higher than average findings. One can argue that FDA audited trial data represents only a small fraction of all clinical trials conducted in China and that trials conducted in support of US or European applications likely are conducted with higher quality but that would need to be verified. One has to give credit to the Chinese FDA to take this very bold step as it surely could adversely affect the entire clinical trial industry in China. Chinese regulators have been historically known to take bold steps like this to rein in violators. So, for sponsors using sites in China, the best course of action is to conduct their own independent audits of clinical trials in China. US FDA was not involved in this investigation. In the past US FDA has declined to ban drugs based on audits by other regulators. Any sponsor using data from trials in China should certainly get a second look from FDA. But unless there are specific concerns about data, FDA will likely keep accepting data from trials in China. The news is still fresh, let’s see how it plays out.