About Clinical Trials

About Clinical Trials and Studies

Advancements in medicine have allowed us to go to a doctor and treat an ailment with prescribed medications when we get sick.

But how are these medications created? And what is the relationship between new drugs and clinical trials?

Developing a new drug requires not only studying the effects and toxicity of a drug candidate in animals but confirming its efficacy and side effects (safety) in humans as well.

Clinical trials that examine efficacy and safety in humans are called "human trials." Clinical trials conducted to obtain approval as a drug from the Ministry of Health, Labour and Welfare (MHLW) are called "drug studies."

GCP and Running Clinical Trials

Clinical trials are conducted according to standards established by the MHLW. These standards for pharmaceutical clinical trials are called "good clinical practice," or GCP.
The physician conducting the clinical study and the clinic explain the clinical trial to the patient thoroughly, and the patient, after fully understanding the explanation and deciding whether to participate, provides consent (informed consent). The human rights and safety of participants are given the utmost respect and confidentiality is safeguarded.

A drug candidate first undergoes testing for efficacy and toxicity in animals ("non-clinical trials"), and once the degree of efficacy and toxicity has been verified, it goes on to a clinical study.
Clinical studies are split into the three phases below, starting from Phase I and progressing to the next phase after safety and efficacy are confirmed.

Creating a New Drug

It usually takes about 3 to 7 years to complete a trial from Phase I to Phase III. Only those that pass the approval screening by the MHLW and receive approval for manufacturing and sales are released to the world as new drugs.

But even after its release, data must be collected as necessary for 4 to 10 years and the drug must once again undergo screening by the MHLW. This is called post-marketing surveillance.

It therefore takes an extremely long time (as many as 15 years) for a drug to be created, and in reality, only a small fraction of drug candidates are actually released as new drugs.
No matter how promising the effects of a drug candidate may be, it will never be used as a drug unless it goes through the process above.