About Clinical Trials

What is a clinical trial?

Clinical trials, also called clinical research studies, are studies performed under the supervision of a physician or research professional.  These studies are done to determine if study medications or investigational medical devices are safe and effective.  Studies look at ways to prevent, detect or treat diseases or conditions. All clinical trials require the approval of regulatory authorities, institutional review boards (IRB) and ethics committees (EC) to protect participants.  

Physician with Patients
What should a participant expect?

Before participating in a clinical trial, the study doctor or their staff will provide key information about the study to help potential participants decide whether to take part in the study. The research team provides an informed consent document that includes details about the trial, such as its purpose, how long it’s expected to last, tests or procedures that will be done as part of the research, and who to contact for further information. The potential participant will be asked to review and sign the informed consent to show they understand the study and the possible benefits and risks. If they qualify to be enrolled in the study, they will be able to discuss their care with the study doctor or research staff during length of time they are enrolled in the study. 

Are there risks in clinical trials?

The risks and benefits of being part of a clinical trial are outlined in the informed consent document. Potential risks will be explained in detail with the participant by the study doctor or research professional. 

Can the participant change their mind and drop out of a clinical trial?

Participation in a clinical trial is voluntary and participants may withdraw at any time. It is important that if you no longer want to participate in a clinical trial you discuss this with the study doctor.  

Where can I find more information about being a participant in a clinical trial?

Additional information about clinical trial participation is available at the United States Food and Drug Administration website here.