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Xinhua: Over 80 Percent of the Clinical Trial Data Submitted Had False Data

Xinhua recently reported that, according to data that the State Food and Drug Administration (SFDA) released, 81 percent of the new medicine registration submissions were denied because the clinical trial data submitted was false. A large amount of the analytical data had no differential tracks, some data lacked trace-ability, some omitted records of adverse reactions, and some data got modified to meet “expectations.” The entire chain in the medical industry has been identified as problematic. This chain includes medicine manufacturers, medicine wholesalers and retailers, doctors, and government inspection and administrative units. This situation is not news – it has been there for years. Research that the Chinese Journal of Clinical Pharmacology conducted in 2013 showed that 85.7 percent of the medicine trial data was found to be “irregular” and the research project found no issues in only one seventh of the organizations conducting trials. Some medicine company owners expressed their anger over the fact that they are “punished” by having to follow a strict and ethical standard – their costs are too high to compete and it actually takes a longer time to obtain approval if they don’t take the “shortcuts.”

Source: Xinhua, September 20, 2016