What is a Clinical Trial?
A clinical trial is a study in human volunteers designed to answer a specific health question about
the safety or efficacy of a drug, a device, or other interventions. These allow doctors to examine
the benefits and risks of using these drugs. Clinical trials are designed to find safe treatments that
work in people and new ways to improve health.
Why Participate in a Clinical Trial?
Clinical trials can either enhance a treatment or be a treatment option. Here are a few reasons
people choose to participate in studies:
- Many, if not all, treatment drugs and tests are free to study participants
- Successful clinical trials may improve the length and quality of life for study participants
- Clinical trials provide an opportunity to take positive action by contributing to the understanding of a disease or condition and by furthering treatment options available to others
- Patients in successful clinical trials are the first to benefit from these cutting-edge treatments
How is a Clinical Trial Conducted?
A consent form, which explains what is involved in the study, is provided to and reviewed with
you by members of the research team. Being in a study is completely voluntary, and you can
change your mind at any time even if you have signed the consent form.
All studies have guidelines about who can participate and these are called inclusion and
exclusion criteria. They are not used to reject interested participants personally, but rather
to help produce reliable study results. You will be monitored carefully during the study, and
you will likely be contacted by the research team after study procedures are completed. Some
studies require more tests and doctor/clinic visits than you would normally have for an illness or
How are Clinical Trial Participants Protected?
US federal agencies including the Food and Drug Administration (FDA) and the National
Institutes of Health (NIH) oversee much of the clinical trials in the U.S. to protect the rights
and welfare of study participants. Institutional Review Boards (IRBs) oversee the centers where
clinical trials are conducted and ensure that a clinical trial is ethical and that study participants’
rights are protected. As a study participant, you have access to the IRB, a volunteer advocate, the
physician and the staff conducting the clinical trial.