About Clinical Research

What is a clinical research study?

Clinical research studies help scientists and doctors find out if a medical device or medication is safe and works in people. Before any medication can be approved and sold, it must go through several steps, called phases, of clinical research:

Phase 1: First study of the drug in people (usually healthy volunteers)

Phase 2: Study of the drug in people with the illness or disease the drug is made to improve

Phase 3: Study to find out how well the drug works to make the illness or disease better

Phase 4: Research to learn even more after the drug is approved and can be sold

The Ri-CoDIFy 3 study is a Phase 3 study.

Why do people participate in clinical research studies?

People participate in clinical research studies for different reasons. Some may participate because they want to learn more about their disease. Others participate because they want to help researchers learn more about a disease to maybe help them and others in the future.

Are clinical research studies safe?

Clinical research studies follow a specific set of rules and are closely watched to help keep all participants safe.

What if I have questions during the study?

You can ask questions of the study team 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 team at any time.

Can I leave the study once it has started?

Study participation is completely up to you! You do not need to take part in the study, and you can stop participating 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 clinic for a final visit for your health and safety, but leaving will not affect the future 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 research study.