コロナワクチン、注目の「治験」　専門家に仕組みを聞く

Corona Vaccine Experts shows how "Clinical Trial" works

What is a clinical trial in the first place?

――What is a clinical trial?

Research conducted on humans to examine the usefulness and safety of pharmaceuticals and medical devices is called "clinical trial". Among them, clinical trials conducted by companies in accordance with laws and ministerial ordinances in order to have the government approve new drugs and new medical devices are called clinical trials in Japan. Patients will want to use safe and effective drugs, and doctors will not know what to administer to what kind of patient without knowing the efficacy, safety and other characteristics. A clinical trial can be said to be a means to gradually and carefully confirm whether a "candidate" for a drug in the future is safe and effective.

――What kind of process is there?

The flow of infection prevention vaccines and therapeutic agents is basically the same, but in order to explain in an easy-to-understand manner, we will explain using general therapeutic agents such as tablets. In the process of developing new drugs, we will confirm the efficacy and safety of therapeutic drug candidates using cultured cells and laboratory animals before starting clinical trials. Especially in the evaluation of safety, it is necessary to carry out animal experiments, and it is common to use mice, rats, dogs, etc. From the viewpoint of animal protection, efforts to reduce the number of animals used and pain reduction are also required.

――From there, you will move on to clinical trials for humans. What steps are there in the clinical trial?

What are the rules for safety and security?

In general, at the stage called "Phase 1", we will check the safety, absorption of drugs and distribution in the body for healthy people. After clearing this stage, the patient will proceed to "Phase 2" to confirm the appropriate dose, dosing interval, dosing period, etc. for the patient. In the final "Phase 3", we will verify the efficacy and safety for more patients using the optimal administration conditions confirmed in Phase 2.

Source: https://www.asahi.com/articles/ASNDM630KNDHUHBI03N.html?iref=comtop_ThemeLeftS_01