What are clinical research studies?
Clinical research studies test investigational medicines or
devices and see if they work as potential therapies for certain conditions.
Before any medication or device can be approved and made available to the
public, it must go through several phases of clinical research.
- Phase 1: First study of the drug in humans
(often healthy volunteers)
- Phase 2:
Study of the drug in people with the condition the drug is designed to improve
- Phase 3: Study confirming how effective the drug
is for improving the condition
- Phase 4: Continued research after the drug is
approved for public use
The KD025-209 study is a Phase 2 study.
Why do people participate in clinical research studies?
People participate in clinical research studies for many
reasons. Some participate because they want to learn more about their disease. Some
are curious to see if a new drug can help their condition. Others participate
because they want to help researchers learn more about a disease to potentially
help them and others in the future.
Are clinical research studies safe?
Clinical research studies follow a specific set of standards and are closely regulated to help protect the safety of all participants. However, all research has some risk. These risks include side effects or reactions related to the study drug. Before agreeing to participate, study staff will provide you with information about common study drug side effects. Because the study drug is still investigational, however, the study team does not know all the ways it can affect the body. You will be closely monitored during the study for side effects.
Before agreeing to participate, make sure that you understand the rights and responsibilities of study participants. If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study team at any time.
Can I leave the study once it has started?
Study participation is completely voluntary. You are not
required to take part in the study, and you can end your participation at any
time, for any reason. If you think you would like to stop participating in the
study, talk to the study doctor. If you decide to leave the study early, the
study doctor may ask that you return to the study site for a final visit to check
your health and safety. Leaving early will not negatively impact the care you
Can I see my regular doctor, or other doctors, during the study?
You can visit any doctor to meet your health needs during
the study. You should let your study doctor know if you are seeing another
doctor and if any other medications have been prescribed. You should also let
your other doctors know that you are participating in a clinical study.