Govt stresses ethics and efficiency in drug tests

As the nation races to find a vaccine, authorities and experts are working to ensure probity and safety. Zhang Zhihao reports.

At a news briefing on Feb 24, Bruce Aylward, an epidemiologist with the World Health Organization, described a major obstacle to research on the novel coronavirus.

He said too many clinical trials are being conducted simultaneously and there are not enough patients to provide samples, which may lead to unreliable results.

"We have got to start prioritizing enrollment into projects that may save lives, and save them faster," he said, adding that the issue is not unique to China, but is global because coronavirus research is moving at breakneck speed.

The government, scientists and officials are fully aware of the problem.

Wu Yuanbin, head of the Bureau for Social Development at the Ministry of Science and Technology, said conducting such trials requires great expertise and oversight. Therefore, last month, the ministry and related central government bodies published a guideline to screen applications and regulate ongoing trials.

The guideline states that the drugs cited in applications for clinical trials should be commercially available and have demonstrated clear efficacy against the virus in lab cells or animal tests.

In addition, the dose for patients receiving the test medication may not exceed the amount recommended in the instructions included in the drug's packaging.

Meanwhile, in an open letter in the Chinese Journal of Epidemiology last month, 12 scientists urged their peers to conduct coronavirus-related clinical research more ethically and rigorously.

They argued that the rapid growth in the number of poorly designed experiments could be a waste of valuable research assets and yield inaccurate results, and may even be irresponsible and pose a risk to patients.

On Monday, the Chinese Clinical Trial Registry, an online public database for applications and approval of clinical trials, noted that about 280 studies were being conducted on the virus, including more than 100 clinical drug trials. The number was a significant rise from the 40 recorded on Feb 10.

The trials include the use of anti-HIV or anti-flu drugs to treat the virus, which had infected more than 80,200 people and killed over 2,980 on the Chinese mainland as of midnight on Tuesday.

Tests were also being conducted to assess the efficacy of interferon and hormone therapies, biological agents such as umbilical cord blood cells, traditional Chinese medicine and even tai chi exercises.

At a media briefing last month, Wu said the large number of simultaneous experiments has resulted in some projects competing for patients and resources.

"So, as we are researching, we are also working on improving management, which will hopefully identify effective drugs in a scientific, efficient and orderly manner," he said.