Clinical Research Overview

What is a clinical research study?

Clinical research studies help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.

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 volunteer to participate because they want to help researchers learn more about a disease to potentially help them and others in the future.

Why do clinical research studies use placebo?

Placebos are an important part of clinical research studies, as they provide researchers with a comparison point for new therapies, so they can prove they are effective and safe. A placebo looks similar to the study medicine but does not contain the active ingredients (like a fake version of the study medication or sugar pill).

Are clinical research studies safe?

Clinical research studies follow a specific set of standards and are closely regulated to help keep all participants safe. Country-specific regulatory authorities and local ethics committee(s) review and approve the study before it can be implemented at an applicable study site. However, clinical research studies do have risk, including development of side effects. The study doctor will also monitor your health while you are in the study.

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 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 clinic for a final visit to ensure your health and safety. There will be no negative impact on 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.