Cloud hangs over China's leading role in clinical trials

(Ecns.cn) – China now has 2,770 registered clinical trials underway, compared to 1,849 in India, according to statistics from Clinical Trials, a website and database of federally and privately supported clinical trials cited by the Southern Weekly.

Experts say low costs, ready access to patient populations and a plentiful supply of researchers make China one of the favorite countries for clinical research.

More and more multinational corporations are coming to China to conduct clinical trials, which means that Chinese patients will most likely be the first to use the latest and most advanced drugs, said Zeng Fandian of the International Union of Basic and Clinical Pharmacology.

However, the protection of patients' interests in clinical trials remains a severe test for Chinese regulators, as a number of drug-related deaths have occurred in recent years.

Volunteer or victim?

Every year, hundreds of thousands of Chinese people volunteer for clinical trials and contribute to the objective evaluation of new treatment strategies. Although the consideration of volunteer health has long been an important part of the code of ethics in clinical research on human beings, it continues to be a very complicated issue in China.

On March 31, 2006, a 54-year-old woman called Wang Liying (not her real name) was diagnosed with final-stage gastric cancer in Beijing. A year later, when she went back to Peking University Cancer Hospital, the year-long treatments had proved unsuccessful and the malignant cells had metastasized.

Just as her husband Shi Deyong was at his wits' end, Pfizer, a US-based multinational pharmaceutical company, approached the couple with a new drug codenamed "su011248" which was under clinical trials at that time.

After reading a 41-page contract with information on volunteer rights, potential side effects and general guidelines on compensation for research-related injuries, the couple decided to give it a shot, since the drug had displayed good therapeutic efficacy against some cancers in previous clinical trials.

In the first few days, Wang felt sick and powerless after taking the drug. On the twelfth day of her trial, Wang's nose started to bleed, so she was immediately sent to Peking University Cancer Hospital again on April 16, 2007.

After the fourteenth day, Wang began to suffer from very serious side effects, including irregular heart function, liver damage and kidney failure. On May 3, 2007, 36 days after starting on the new drug, Wang passed away due to a cerebral hemorrhage and respiratory failure.

Deeply distraught, her husband filed a lawsuit against Pfizer claiming that the drug had led to his wife's death. After a four-year legal fight, the Beijing No. 1 Intermediate Court awarded Wang's family 300,000 yuan (US$47,460). Yet even today, Pfizer will still not admit to fault in the case, reported the Southern Weekly.

300,000-yuan guinea pig

Pfizer told Southern Weekly that there had been no evidence that the new drug had led to Wang's death, and that the money paid to the woman's family was not compensation for her death, but compensation based on the principle of equitable liability.

However, according to Clinical Trials, a total of 78 patients around the world took part in the clinical trial for the drug "su011248" and eight died shortly after taking it.

Despite that result, the drug (now named Sutent) is available on the market and has received approval in over 100 countries and regions, and more than 100,000 patients in the world have taken it for cancer treatment, according to Pfizer.

In the company's annual report, Pfizer earned revenue of US$1.066 billion from Sutent in 2010.

An insider revealed that currently the successful development of a new drug normally requires US$1 billion in funding and ten years to ensure its safety. Once approved and introduced into the market, it will bring about huge profits within the term of patent protection.

Behind the multi-digit numbers, clinical trial participants like Wang Liying have obviously contributed greatly to the cause of medicine and human health, but few will remember their sacrifices.

Protecting trial participants

In the field of oncology, very few eligible patients can enter into trials, and most treatments have only been tested on a small percentage of patients. One important reason is the lack of facilities, despite the presence of the many talented investigators and clinical scientists.

Early in March, it was reported that China planned to set up a Global Clinical Trial and Research Center at the Tianjin Biotechnology Research Park, located 137 kilometers southeast of Beijing, with global support and 50 million yuan (US$7.9 million) from the government. The center will be tasked with building an e-platform for clinical trials and developing a global clinical trial network to promote high-quality clinical research in the world, according to China Daily.

With efficient infrastructure to facilitate and monitor clinical trials, another issue of equal importance is how to protect the interests of clinical trial participants. In Wang Liying's case, terms of compensation were not written in the details of the contract, according to the Southern Weekly.

The government should quickly draft guidelines addressing issues related to compensation for research-related injuries to protect volunteers.

According to the Ministry of Health, a regulation concerning ethical review for biomedical research on human participants is to take effect in 2012.