phase 3 (study) phase 3 (study)
A step in clinical research that includes a large group of participants who have a disease or condition to find out how well a study treatment works and how safe it is, compared to other treatments or a placebo.
Example of phase 3 (study) in a sentence
Some participants in a phase 3 study may receive the new study treatment while other participants receive the standard of care.
More Info
Phase 3 studies follow phase 1 and 2 studies that have met their endpoints. Phase 3 studies enroll even more participants than phase 2 studies and can last a longer time.
In phase 3 studies, participants are usually separated into two or more groups. Some participants will be taking the new study treatment while others could be taking other treatments that are already approved and in use. During a phase 3 study, researchers are comparing the new study treatment to existing treatments or a placebo.
You may also hear about a phase 3b research study. The study team may want to signify if a research study is in a later stage of a phase 3 study.
Other info to think about when joining a study
You may see the term phase 3 in the protocol or consent form about a research study you are interested in joining. The study team may also talk about you joining a phase 3 study when they are talking to you.
You may want to ask the study team what is the standard of care they are using as a comparison in the research study you are thinking about joining.
If the study includes a placebo you may want to learn more about the reason the study is using a placebo and why there is no other treatment comparator.
You can also ask about what happened in previous phase 1 and phase 2 studies that was researching the new study treatment and if there are any articles available about the studies.
If you hear that the research study is a phase 3b study, you can ask the study team to clarify what it means.
