80% of Chinese clinical trials’ data fabricated
pharmafile | September 28, 2016 | News story | Manufacturing and Production, Research and Development | China, Fabrication, corruption, report
The government review of clinical trial practise involved 1,622 programs of new pharmaceutical drugs waiting upon government approval to begin mass production. According to the report, the data gathered during the clinical trials failed to meet analysis requirements, were incomplete or were untraceable.
The SFDA report concluded that some of the companies involved were thought to have hidden or deleted records of potential adverse effects and tampered with the data that did not meet projections. As a result, more than 80% of applications for mass productions of newly developed drugs have been cancelled.
Though the extent of the scandal may be surprising, there has long been an awareness of issues within China’s pharmaceutical practises. Third party agencies that are tasked with inspecting facilities, known as contract research organisation, are quoted by the report as being “accomplices in data fabrication due to cutthroat competition and economic motivation”.
The root of the issue is then not regulation, with regulation for clinical trials running on similar lines to Western practises, but in the lack of adherence to them. China’s generic drug industry has struggled with quality problems and therefore there is a temptation for companies to manipulate data to meet standards. The report found that many of the new drugs were found to be a combination of existing drugs, with clinical trials outcomes written beforehand and the data tweaked to fit in with the desire outcomes.
Ben Hargreaves
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