China to step up oversight of clinical trials for virus drugs

China will enhance regulation and ethical oversight for clinical trials of drugs and treatments against the COVID-19 epidemic, thus ensuring research assets are well-spent and patients can receive safe and effective treatments, an official said on Friday.

Wu Yuanbin, head of the Ministry of Science and Technology's bureau for social development, said 234 experiments related to the virus, including 105 clinical trials for drugs, have been registered in China.

The tested drugs included chemical and biological agents, as well as traditional Chinese medicines. "Most of these drugs in trial are market drugs, so their safety is somewhat guaranteed," he said.

However, Wu said with so many experiments going on, there are instances of projects competing for test patients and resources. As a result, the ministry with other related central government departments have published a new guideline this week to screen applications and regulate ongoing trials, he said.

These rules include that the drug applying for clinical trials should be market drugs that have demonstrated clear efficacy against the virus in lab cells or in animal tests. The dosage for patients receiving the test drugs cannot exceed the recommended amount of the drug's manual.

The institutions carrying out the clinical trials must be hospitals designated to treat the disease, and they include the makeshift hospitals in Wuhan, he said. The person responsible for running the clinical trial must also be a senior expert who can formulate detailed experiment and risk management plans.

All clinical trials must undergo ethical inspections and report their files to the proper authorities. The findings of these clinical trials will also need to be announced through official government channels, he said.

For trial drugs included in the diagnosis and treatment guideline for COVID-19 published by the National Health Commission, Wu said those drugs have been carefully selected by expert committees based on their potential.

"We hope to select more effective drugs and treatments through high-quality clinical trials," he said.