All Questions

Which phases does a research project have?

Clinical studies are divided into four phases. Each phase has its unique purpose to help researchers answer various questions and make the procedure as safe as possible for the participant.

• Phase 1: The study drug is tested for the first time in small groups with only healthy participants (20-80 participants) to evaluate safety, determine a safe dose of therapy and identify possible side effects.
• Phase 2: The study drug is given to a larger group of participants with a specific disease (100-300 participants) to see if the study drug has an effect and to evaluate the investigational medication’s safety.
• Phase 3: The study drug is given to a large group of people (1000-3000) to confirm the investigational medication’s effect, to monitor side effects, to compare the study drug with older, existing medications, and to collect information so the study drug is used safely.
• Phase 4: This stage is also called post-marketing studies that examined how safe medications are after the products have entered the market. These examinations will take place after the study drug has been approved. This stage provides additional information about the drug’s risks, benefits and very rare side effects.