CFDA head says clinical trial problems a 'cancer' on the industry

CFDA director Bi Jingquan

Officials from the China Food and Drug Administration (CFDA) are continuing to crack down on fraudulent clinical trials on the mainland and recently brought together officials from Beijing, Shanghai, Guangzhou, Chengdu and Wuhan representing three hospitals, 10 large pharmaceutical business leaders and association representatives.

The meeting follows several reports that results from various clinical trials in China were fraudulent or faked or that negative test results were deleted in order to get drugs approved.

The director of the CFDA, Bi Jingquan, presided over the meeting and told attendees that the results from investigations into the tests were a "shock" to officials and called the faked test results a "cancer" on the development of mainland drugs that was "seriously affecting the transformation and upgrading of the pharmaceutical industry and its social credibility," according to a statement by the CFDA.

The officials attending the meeting said problems of nonstandard data, incomplete tests and false data showed that pharma researchers, medical institutions and others involved in drug manufacturing were not taking "responsibility" for their actions and said the entire industry must be "reborn" to regain the trust of the people.

Bi said the practice of falsifying data has "deep historical and social reasons," and while the country's reforms and opening up to the West had solved access to medicines, there was still a "large gap" between East and West when it comes to "drug quality and efficacy of the product" as well as "weak regulatory oversight of clinical trials" and "weak technical reviews" of drugs made domestically.

Bi said the country should "punish intentional fraud," but should also "distinguish between falsified data" and data that were "not standardized." He also said companies should be allowed to "withdraw" suspect drugs from consideration for approval, saying it was at the individual company's discretion.

Bi said the government would work with medical institutions and other researchers to improve clinical trials management and research and development and that the government would work to speed up the drug marketing authorization system.

Bi also said the government would work to create a "vocational drug inspector team" to speed up drug reviews and would work to improve communications between applicants and reviewers.

- here's the release (in Chinese) from the CFDA

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