Clinical Research Glossary

phase phase

CDISC

A step in the overall clinical research process to test a new drug, device, or treatment.

Example of phase in a sentence

Research is done in phases to make sure a study treatment is safe and then whether it works before it is approved.

More Info

A phase is a step in the research process. Phases of research studies build on each other and each phase has a separate goal.

Phase 1 studies are usually the first to enroll humans and test for safety.

Phase 2 studies test if the drug, device or treatment works.

Phase 3 studies compare the study treatment to the usual, standard treatment.

Phase 4 studies continue to collect data after a study treatment is approved. These are sometimes called post-marketing studies.

Other info to think about when joining a study

You may see the term “phase” when you are reading about clinical trials.

Before you enroll in a clinical trial you may want to ask about what phase the study is in. You may also want to know more about the information the study team already has about the risks and benefits of the study treatment that is being tested.

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