phase 2 (study) phase 2 (study)
A step in clinical research that gives a study treatment to a small group of participants who have a disease or condition, to look at the study treatment’s safety, and its effect on the disease or condition.
Example of phase 2 (study) in a sentence
A phase 2 study can provide researchers with more safety information about the new study treatment.
More Info
Phase 2 studies help researchers determine if the study treatment is safe and has enough of an effect to move on to even larger research studies.
A phase 2 study usually includes participants with the disease, condition, or symptom for which the new study treatment was intended.
Phase 2 studies will usually have more participants than a phase 1 study and may also last longer, but the number and duration depend on the disease or condition. For example, research related to a rare disease may enroll fewer participants.
Early (phase 2a) studies often assess dosage, frequency, and signs of drug activity. Later (phase 2b) studies focus on dose response and early signs of response.
Other info to think about when joining a study
You may see the term phase 2 in the protocol or consent form and the study team may use the term when they are talking to you.
You can ask the study team what happened during the earlier (phase 1) studies of this study treatment. For example, were there any effects that the researchers were not expecting? Were there were any adverse reactions or serious concerns? You can also ask the study team who to contact if you have any questions or if you are not feeling well during the study.
If you hear that the research study is a phase 2a or phase 2b study, you can ask the study team to clarify what it means.
