Phases 1 to 4

 

 

 Clinical Trials are conducted in Phases. The trials at each phase serves a different purpose and help scientists answer different questions:

 

·       In Phase 1 trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.


·       In Phase 2 trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.


·       In Phase 3 trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.


·       In Phase 4 trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.


CISCRP (2010) Clinical Trial FAQs. From Center for Information and Study on Clinical Research Participation (CISCRP)