80% of China’s clinical trial data are fraudulent, investigation findsBMJ 2016; 355 doi: https://doi.org/10.1136/bmj.i5396 (Published 05 October 2016) Cite this as: BMJ 2016;355:i5396
- Michael Woodhead
Just over 80% of clinical trial data submitted to support new drug registrations in China have been revealed as fraudulent or substandard by the country’s drug regulator.
An investigation of data for 1622 new drugs submitted to China’s State Food and Drug Administration (CFDA) for registration said that 1308 of the applications should be withdrawn because they contained fabricated, flawed, or inadequate data from clinical trials.1
In a damning report released on 9 September the CFDA described the findings of widespread fraud as shocking and vowed to crack down on what it described as a “chaotic” situation in the country’s clinical trials industry.
Much of the blame was attributed to the country’s loosely regulated clinical research organisations, which industry insiders claimed operate in …