Clinical Trials Guide

Clinical Trial

Today, many types of drugs are used to combat various diseases and injuries. However, there are still many diseases and injuries that cannot be overcome. What people living with such diseases and injuries hope for... It is the birth of a new medicine that is more effective, safer, and more reliable.

Clinical trials are studies conducted to confirm whether drug candidates discovered and developed through the relentless efforts of researchers are truly safe and effective. Furthermore, clinical trials are conducted to obtain approval from the MHLW (Ministry of Health, Laboure and Welfare) to use a drug candidate as a drug.

In a clinical trial, we must fully protect the human rights and safety of those who cooperate with us because they are actually taking a drug candidate that is still in the development stage. We must also accurately and scientifically evaluate the safety and efficacy of drug candidates because the future of people who are looking forward to the birth of a new drug is at stake.

For this reason, various strict rules are set by law for conducting clinical trials. Under the strict rules, only drug candidates that have passed the rigorous screening process can be delivered to patients as drugs.

Clinical Trial Process

Basic Research

Discovery and synthesis of drug candidate compounds.

Non-clinical Studies

Using animals to study safety, efficacy, toxicity, pharmacokinetics (how drugs are absorbed, metabolized, and excreted in the body), etc.

Clinical Trials

Phase I trials

Investigate safety, pharmacokinetics, etc. in humans in a small number of healthy adults.

Phase II trials

To study the efficacy and safety of the drug in a small group of patients, and to further investigate appropriate dosage and administration methods.

Phase III trials

Confirm the effectiveness and safety of the drug in a large number of patients.

Application and Permission to the MHLW

The results of the clinical trial are submitted to the MHLW for review and approval. Only after approval can the drug be marketed as a "drug”. Of the drug candidates that start from basic research, only about one in 10,000 will make it to this stage, and it is said to take 10 to 15 years.

Post Marketing Clinical Trial

Gather information on drug that could not be discovered during the development phase based on the results of use by more patients after market launch

Page Top