Clinical Trials
What is a Clinical Trial?
The development of a new drug requires a long period of research and development.
Potential drug candidates are identified from chemically synthesized compounds, natural substances (such as plants, soil bacteria, or marine organisms), and other sources. These candidates are tested in laboratory experiments and animal studies to evaluate their effectiveness against diseases and potential safety for human use. Only substances that show promise in these preclinical studies proceed to clinical trials in humans to determine whether they can be used for disease treatment.
What is a Clinical Trial vs. a Drug Trial (Chiken)?
A clinical trial refers to studies conducted in humans to evaluate the effectiveness and safety of new treatments. Among these, clinical trials conducted to obtain regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for a drug’s official use as a pharmaceutical product are called “Chiken” (drug trials).
Chiken is the most critical stage in the evaluation of new drugs. To ensure the safety of participants, drug trials are conducted in accordance with Good Clinical Practice (GCP), which is a set of national regulations governing clinical trial conduct. These trials are carried out carefully and rigorously under strict regulations to protect patient safety.
New Drugs are Made Possible Through the Cooperation of Many Patients and Participants
Developing new medications would not be possible without the understanding and cooperation of patients and healthy volunteers who participate in clinical trials.
Phases of Clinical Trials
Drug trials are generally conducted in three main phases:
Phase 1
- Conducted in a small group of healthy adults.
- Evaluates the basic safety of the investigational drug.
- Examines how the drug is absorbed into the body, how it is metabolized, and how long it takes to be excreted via urine or feces.
Phase 2
- Conducted in a relatively small number of patients.
- Determines whether the drug is effective and safe for treating the disease.
- Assesses the appropriate dosage and how well the drug is absorbed in the body.
Phase 3
- Conducted in a larger number of patients.
- Confirms the final effectiveness and safety of the investigational drug.
- Often compares the new drug with existing standard treatments to evaluate its advantages and potential risks.