China issues guideline for regulating COVID-19 drug clinical trials

Source: Xinhua| 2020-02-28 19:19:17|Editor: huaxia

BEIJING, Feb. 28 (Xinhua) -- China has issued a directive to regulate clinical trials of potential drugs for the novel coronavirus disease (COVID-19).

Titled "The Guideline on regulating clinical trials of COVID-19 drugs among medical organizations," the document aims to ensure the drug screening run in an orderly and efficient way, said an official from the Ministry of Science and Technology (MOST) at a press conference Friday.

According to the document, drafted by the National Health Commission, the MOST and the National Medical Products Administration, drugs for clinical trials should be medicine that has already been on the market and the efficacy has been proved in animal and in vitro studies, said Wu Yuanbin, director-general of Science and Technology for social Development with the MOST.

The person in charge of the trial should meet certain eligibility requirements and is able to make risk management plans.

Meanwhile, the hospital, researchers and local health authorities that are engaged in a clinical trial should conduct ethical reviews of the trial and put on file.

The State Council inter-agency task force will coordinate medical institutions to undertake clinical trials for recommended drugs and release information of the clinical trials, so as to strengthen the overall planning of the resources and improve the efficiency of the trials.

Noting that too many clinical trials may waste resources and impact the treatment of patients, Wu said that China hopes to screen and expand the use of effective drugs and treatments in an orderly fashion.

The convalescent plasma therapy and Chloroquine Phosphate are good examples of drug screening and trials to be included as recommended under the State Council's joint prevention and control mechanism for the epidemic, he noted.

According to Wu, 105 of 234 clinical trials registered with the Chinese Clinical Trial Registry focus on COVID-19 drugs.