Understanding Clinical Trials
What is a Clinical Trial?
In the final stage of efficacy and safety testing, it is necessary to investigate whether a drug is really safe and effective when used on humans and how much is appropriate to use. This testing on humans is a "clinical trial" and is an "essential course" for a "drug candidate.
Rules of Clinical Trials
There are strict rules to protect the human rights and safety of those who participate in clinical trials to the greatest extent possible, and to accurately investigate the efficacy and side effects of "drug candidates" in a scientific manner. Clinical trials are conducted in accordance with the rules of the "Standards for Conducting Clinical Trials on Drugs (GCP)" based on the Pharmaceutical Affairs Law.
People Involved in Clinical Trials
Clinical trials involve a variety of people, including physicians, clinical trial coordinators, pharmacists, nurses, and pharmaceutical companies, with the patient at the center. Each plays a role and cooperates with each other to ensure that patients can participate in the clinical trial with peace of mind.
How to Participate in Clinical Trials
If you wish to participate in a clinical trial, a medical expert must make a medical judgment as to whether or not your disease condition and symptoms are suitable for the purpose and plan of the trial. If you wish to participate in a clinical trial, please consult with a physician at the medical institution where you are currently receiving treatment.
Further information
More detailed information about clinical trials is available here.