Four in five new pharmaceutical drug applications in China are suspected of clinical data fraud
Four in five new pharmaceutical drug applications in China over the past year failed the standards of the nation’s regulator due to widespread clinical data fraud, a Chinese media investigation has found.
Fabricated or non-existent data and missing adverse event records were among the critical issues identified in an internal China Food and Drug Administration (CFDA) review of 1,622 new pharmaceutical drug applications, China’s Economic Information Daily reported, quoting CFDA insiders and industry sources.
The report found that many of the “new” drugs awaiting approval were actually a combination of existing drugs, and that many clinical trial outcomes were written before the trials had actually taken place, and the data had been manipulated to match what companies wanted to find.
The investigation gained international attention when it was picked up and translated by the US government-run news organisation Radio Free Asia this month.
“The integrity of [China’s] clinical trial infrastructure is poor,” China healthcare market analyst Benjamin Shobert, from Rubicon Strategy Group, said.
The CFDA likely made the bold public disclosure as damage control given China’s “dysfunctional” medical approvals process was rife with delays, Mr Shobert said.
“If you are a bureaucrat at the CFDA, it is in your interests to make this story public and make sure consumers, the government, and industry knows the scale of the problem you are dealing with and that you are not its cause.”
Mr Shobert considered the disclosure good news that showed drug regulation was tightening in China.
