At the press conference on the 28th, a reporter asked, recently, there are media reports that there are more than 200 clinical trials registered since the outbreak, a large proportion of which are about drugs. As far as I know, only 5 drugs are qualified for clinical trials, but 73 drugs are undergoing clinical trials.. Some hospitals in Wuhan even have the situation that patients are not enough for clinical trials and are robbing patients. We are looking for drugs for better treatment. But does the clinical trial of this scale interfere with the treatment and affect the treatment of patients. What does the research team think of this?
In the absence of targeted, specific and effective antiviral drugs, searching for available drugs is an important way to treat life.
Such a large-scale clinical trial of drugs, even there are too many trials, not enough data situation.
In clinical research, if the sample size is insufficient, the selection of the control group is unreasonable, the randomization and masking of the groups are not strictly implemented, the evaluation criteria of the efficacy indicators are not objective, and the integrity and authenticity of the data are not fully guaranteed, these clinical studies are difficult to provide high-quality evidence of effectiveness and safety, which makes the efforts of the patients, researchers and management departments put into practice East stream.
Wu Yuanbin confirmed this fact. We have made a preliminary statistics. There are about 234 clinical studies registered in China clinical trial registration center, including 105 clinical studies of drugs, and some related to testing reagents, devices, etc. In drug research, including traditional Chinese medicine, chemical medicine, biological medicine, and most of them are already on the market
How to solve this problem?
Novel coronavirus pneumonia novel coronavirus was published in February 25th. In order to standardize, scientific, orderly and highly effective clinical research on drugs, the State Council issued the notice on regulating the clinical research on drug treatment of new coronavirus pneumonia in medical institutions.
It is clearly stated in the notice that in carrying out clinical research on related drugs, priority should be given to treatment and epidemic prevention and control, so as to firmly prevent the research from affecting the treatment of patients and the overall epidemic prevention and control.
Wu Yuanbin said that in the process of tackling key problems, organizations are also being strengthened, hoping to find good drugs scientifically, orderly and efficiently. Notice itself is to further regulate the clinical research work of listed drugs.
To this end, the circular puts forward three measures.
The first is to define the conditions for research. The drugs for clinical research should be listed drugs, which have been verified to be effective by in vitro and animal experiments.
A novel coronavirus pneumonia treatment designated hospital should be established at the county level or above, including the shelter hospital. It also puts forward the corresponding qualification requirements for the person in charge of the research, which should be a licensed doctor above the deputy high level, who can formulate plans and management measures for the possible risks.
The second is to further standardize the research procedures. The hospital and the person in charge of the drug clinical research should carry out ethical review and project approval according to the requirements of the measures for the management of clinical research projects carried out by medical institutions, and file as required, and carry out the quality control and risk control in the whole process.
Third, we need to speed up the application in an orderly manner. The scientific research team recommended the effective drugs to the joint prevention and control medical treatment group, and the medical treatment group studied whether to expand the scope of use or to include in the diagnosis and treatment plan.
According to Wu Yuanbin, convalescent plasma is considered to be an effective treatment after some studies in the early stage, which is included in the corresponding treatment plan. In the sixth edition of the guidelines, chloroquine phosphate was included, which was also proposed according to the effect after the previous study.
The next step is to screen out more effective drugs through standardized, scientific, orderly and efficient drug clinical research. Said Wu Yuanbin.