CLINICAL TRIALS………… JAPAN

Clinical trials, also known as clinical studies, are scientific studies of drugs, medical devices or other treatments in humans. These studies are most often conducted for the following reasons:

• To verify the safety and effectiveness of potential drugs, medical devices or other treatments,
• To compare trial-treatments against existing treatments,
• To determine better ways to use treatments to make them more effective, easier to use, or to decrease side effects,
• To determine how best to use a treatment in a specific population. For example, in children or in a particular ethnic group.

There are three main stages in clinical trials for drug development: Phases I, II and III. Phase I clinical trials are conducted with 50~200 healthy participants and involve incremental dose increases of investigational drug within a predefined dose range to evaluate tolerability and safety, monitor food and drug interaction, as well…