CHINA TOPIX

12/22/2024 04:47:15 pm

Make CT Your Homepage

At Least 80% of Chinese Clinical Trials are Fabricated, Government Study Reveals

Prescription medication is pictured on May 15, 2014 in Auckland, New Zealand.

(Photo : Getty Images) Prescription medication is pictured on May 15, 2014 in Auckland, New Zealand.

At least 80 percent of China's clinical trials on pharmaceutical drugs were fabricated, according to a Chinese government investigation.

China's State of Food and Drug Administration (SFDA) carried out a one-year review of 1,622 clinical trial programs, conducted for new pharmaceutical drugs waiting for approval for mass production. Investigators discovered that at least 80 percent were "fabricated."

Like Us on Facebook

They found that the questionable data failed to meet analysis requirements, were incomplete, or untraceable, the Next Shark reported.

The SFDA said that the scandal is a result of "breach of duty by supervision departments and malpractice by pharmaceutical companies, intermediary agents, and medical staff."

Interestingly, the scandal came to no surprise for industry insiders, with one physician who refused to be named saying "Clinical data fabrication was an open secret even before the inspection."

It is said that China's generic drug industry is facing quality problems thus the need to alter and manipulate clinical trial findings to meet the high standards on paper, Newsgram pointed.

According to Economic Information Daily, clinical trial outcomes have already been written beforehand, with data about combinations of drugs that already exist in the market, with the help of third-party research organizations.

"The domestic market for Western pharmaceuticals in China is either confined to a very straightforward generic products that have been around for a long time... or resolves around joint venture pharmaceutical manufacture with foreign companies," Luo Liang, a health professional, told Radio Free Asia.

"Either that or Chinese pharmaceutical companies get hold of the formula for certain drugs whose patents have expired. There are no new drugs in development in the same way that there are overseas," Luo continued.

Real Time Analytics