A recent government report has claimed that up to 80 per cent of China’s clinical trials have been fabricated. The data from a total of 1,622 pharmaceutical clinical trials, where drugs were awaiting approval for mass production, was examined over a 12-month period, with the investigators finding that the reported results were either incomplete, absent or untraceable.
The State Food and Drug Administration (SFDA), China’s pharmaceutical drug regulator, suggested that the clinical trial scandal was the result of poor supervision and malpractice by medical staff, intermediary agents and pharmaceutical companies, with some Chinese drug companies being accused of deliberately tampering with or hiding unfavourable data after testing. Initial reports in the media also claim that the pharmaceutical companies have deliberately hidden evidence on the side effects of some of the tested drugs, meaning that the trials haven’t met the regulatory requirements.
Whilst 80 per cent seems like an incredibly high proportion, industry insiders are not too surprised by the findings. One hospital chief claims that data fabrication in clinical trials was an open secret for a long time prior to the government inspection. Indeed, many suggest that the results of these clinical trials are written before the trial is even carried out.
Officials state that there are strict regulatory guidelines controlling clinical trials within China that were updated last year; however, pharmaceutical companies rarely comply with these regulations as they may fail to make a profit if they do.
Whilst there are no reports of poor staffing levels in these trials, the use of reputable clinical trial services would have prevented this scandal from occurring. Companies such as http://www.gandlscientific.com/ provide highly trained clinical trial assistants, scientists, managers and directors who operate ethically and with integrity.
As a result of the findings, more than 80 per cent of the applications for the mass production of new pharmaceutical drugs have been cancelled, with government officials suggesting that further evidence of malpractice is likely to be unveiled. There is also evidence to suggest that many so-called new drugs are merely combinations of existing drugs whose safety profiles are likely to be incomplete. With corruption being evident at this level, it is unsurprising that the falsified data figure is so high, with further claims of bribery also being reported in the media.