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Health gamble
Ren's illusion that his participation was worthy of respect was shattered when he began to understand more about the background to the trials, especially when he learned that some "experienced" participants took part in two or three trials at the same time.
"By rights, there should be at least three months between each trial to ensure that the target is clean," said a director named Li, who works for a drug company and has overseen trials for four years.
She said some participants in the second, third and fourth phases of testing already have the condition the trial drug is meant to treat and, despite the risks, hope to benefit by offering their services.
"By contrast, 'professional' participants are gambling with their lives just for money. The result of this deception is not only likely to harm them, but could also lead to severe losses for the pharmaceutical companies and those being treated with the drugs," Li said.
Those who have participated in a large number of trials may also display an unconscious tendency to produce the sort of response they feel the doctors want, rather than an honest appraisal of the product. "They are very familiar with the procedures and may involuntarily produce a 'good' result in line with the tester's desired response," she said.
Payment poser
Some regular participants feel the payment on offer is not commensurate with the risks they face. The hospitals take the lion's share of the payment, often leaving participants with around 10 percent of the total amount, according to Ren.
"I once saw the payment details on a doctor's computer," he said. "I was told I would be paid 2,500 yuan, but the budget was 30,000."
During tests on a new brand of insulin, Ren was told that the drug company provided 9,000 yuan for each participant - a huge increase on the usual payment - but he and his fellow guinea pigs received less than half the promised amount.
"We only got 4,000 yuan because the doctors took the rest of the money. We didn't dare complain, though. If we had, we would never have been chosen to take part in trials again."
Li said the practice is an open secret in the industry, but the companies are unable to help. Hospitals naturally want to be reimbursed for the time and trouble they've taken and there is no requirement in China forcing doctors and testers to confirm payment details on the participant's contract.
"In Europe, the payment is written into the contract, which ensures the participants' interest," Li said. According to the regulations, drug companies are not allowed direct contact with the participants because only the hospital has that right.
Lack of protection
Wang Chenguang, a professor specializing in pharmaceutical law at Tsinghua University, said "professional" participants exist in most countries, but the laws and regulations in China lag far behind those overseas.
He said the 1985 Drug Administration Law lacks provision for the division of responsibility among the regulatory departments.
"In particular, there are no specific and operational implementation rules to govern the transparency of the review and approval process, or to prevent the abuse of regulatory discretion. Also, liability insurance for clinical trials doesn't exist, neither do specific measures to protect a participant's personal information or settle disputes," he said.
Contact the writer at yangwanli@chinadaily.com.cn
Jiang Xueqing contributed to this story.
