03 October 2016 | News | By BioSpectrum Bureau
Nearly 80% of data in Chinese clinical trials have been fabricated
The SFDA found that the more than 80 percent of the data failed to meet analysis requirements, were incomplete, or totally non-existent.
Singapore: A recent investigation led by the Chinese State Food and Drug Administration (SFDA) revealed that nearly 80 percent of the data used in clinical trials of new pharmaceutical drugs have been "fabricated." The investigation looked at data from 1,622 clinical trials for new pharmaceutical drugs currently awaiting approval.
With these fraudulent activities coming to light nearly 80 percent of current drug applications, which were awaiting approval for mass production, have now been cancelled. The SFDA found that the more than 80 percent of the data failed to meet analysis requirements, were incomplete, or totally non-existent.
The report also mentioned that many of the 'new' drugs awaiting approval were actually a combination of existing drugs, they also showed that many clinical trial outcomes were written before the trials had actually taken place, and the data had been simply manipulated to match what companies wanted to find.
With all these findings, Chinese pharmaceutical industry is in a big trouble and the SFDA has to now worry about the drugs that were marked safe and approved. Experts said that industries donot adhere to the guidelines and follow the regulation.
The SFDA report was released by the state-owned Economic Information Daily Newspaper, and, as yet, there's no English version available online to go over with a fine-toothed comb, so for now, we're taking the Chinese media's word for it. But as shocking as it all sounds, Economic Information Daily Newspaper also cites unnamed industry insiders who weren't surprised in the slightest at the revelations.