What are clinical research studies?

Clinical research studies help scientists and doctors explore whether a medical strategy, drug, or device is safe and effective for humans. Before a new drug or device can be used for therapy, it must go through several phases of clinical research:

 

Phase 1

Phase 1:  First study of a new drug in people.

Phase 2: Study to learn if a new drug is safe and understand how it affects certain health conditions.

Phase 3: Study confirming if a drug is effective at improving a health condition

Phase 4: Continued research after a drug is approved for public use.

Brightn is a Phase 2 study.

Why do people participate in clinical research studies?

People participate in clinical research studies for a variety of reasons. Some may participate because they want to learn more about their disease. Others volunteer to 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 ensure the safety of all participants.

What if I have questions during the study?

You can ask questions of the study staff at any time before, during, and after the study. Before agreeing to participate, make sure that you understand the 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 staff at any time.

Can I leave the study once it has started?

Study participation is completely voluntary. You do not need 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 you should leave the study early, the study doctor may ask that you return to the study site for a final visit to ensure your health and safety. There will be no negative impact on the care you receive.

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 that you will be seeing another doctor and if any other medication has been prescribed. You should also let your other doctors know that you are participating in a clinical study.