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80% of clinical testing data for new drugs suspected to be fraudulent

(People's Daily Online)    15:41, September 20, 2016

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According to data released by the China Food and Drug Administration (CFDA), as of January 2016, 1,184 drug registration applications had been rejected by the CFDA or withdrawn by pharmaceutical enterprises because of fake or incomplete clinical testing data.

The implications of this admission are significant: 73 percent of new drugs are involved, according to a report by Science and Technology Daily on Sept. 20. What's more, that number would shoot up to 81 percent if the 165 new drugs that were exempt from clinical testing were eliminated.

One year has passed since the CFDA began its investigatation, asking enterprises to conduct self-inspections of their clinical testing data. The results showed that over 80 percent of the new drugs were suspected of faking clinical test data. Supervision procedures have failed to tackle the problem, and enterprises, drug agents and doctors are all complicit in this violation of the law.

Officials from the CFDA explained that, in the course of their investigation, they discovered that the clinical data of many drugs was incomplete, or failed to cite reliable sources. Some pharmaceutical enterprises purposely concealed adverse drug reactions and altered test data that didn't meet expectations.

Clinical test results are not only the sole criterion of the safety and efficacy of new drugs, they are also key evidence in the approval of a drug for registration and sale. Yu Pei, director of the Pharmacology Department of Jinan University, said that clinical test results should be standardized, precise and reliable, as they are the most important safety guarantee of new drugs.

To solve the problems currently plaguing clinical testing data, experts suggested that it is essential to learn from the experience of developed countries and harshly punish data fraud. In addition, China should involve more doctors in the process of clinical testing to better control the quality of the data. What's more, a third-party supervision system should be established to disseminate the data. 

(For the latest China news, Please follow People's Daily on Twitter and Facebook)(Web editor: Kong Defang, Bianji)

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