China rolls out stricter controls on clinical research for COVID-19 medicine
Global Times
Source:Global Times Published: 2020/4/5 12:53:40
The State Council, China's cabinet has issued a notice on Saturday to further standardize the clinical research of medicine amid the outbreak of novel coronavirus.
According to the notice, clinical research must be approved and reviewed by medical institutions and be supervised by medical and technological authorities during the process.
The medical institution must sign a clinical research project agreement with the person in charge of the clinical research, and upload the project on a register platform within 3 days.
For Clinical research that has already been undertaken, institutions should complete the registration and the information upload process within 3 working days. Those that don't complete such registration before the deadline shall not continue to carry out clinical research.
Provincial health administrative departments should follow up on the progress of clinical research, summarize and transfer the results to the scientific and technological administrative authorities at the same provincial level, which will report to the national level of Ministry of Science and Technology.
The usage, contraindications, possible toxins and side effects collected from the research will be reviewed and analyzed by a panel of experts.
For clinical studies with obvious toxic side effects or no clear treatment effects, the scientific research team shall request the medical institution to terminate the research.
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