Rochester Clinical Research
RCR works towards advancing medicine and changing lives by conducting clinical research studies with the help of volunteers from the community. Come Be Part of the Solution and join a study today!
What are the phases of
clinical trials?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
• Pre-Clinical Phase—before clinical trials are conducted, researchers spend many years testing medications in the laboratory and in animal studies, to determine their safety and usefulness.
• Phase I 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. • Phase II 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.
• Phase III 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.
• Phase IV trials, post-marketing studies delineate additional information including the drug's risks, benefits and optimal use.
• Pre-Clinical Phase—before clinical trials are conducted, researchers spend many years testing medications in the laboratory and in animal studies, to determine their safety and usefulness.
• Phase I 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. • Phase II 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.
• Phase III 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.
• Phase IV trials, post-marketing studies delineate additional information including the drug's risks, benefits and optimal use.
