Frequently Asked Questions (FAQ's)?

Why should I participate in a clinical trial?

Study participants can play a more active role in their own health care, gain access to new treatments before they become widely available, and help others by contributing to medical research. 

Who can participate in a clinical trial?

People with the condition being studied, as well as healthy people, can volunteer to participate in a clinical trial.  Before joining a study, a participant must qualify by meeting specific guidelines set by the study designers.  These guidelines are called inclusion and exclusion criteria.  These criteria help ensure that researchers will be able to answer the questions they plan to study.

Who is part of the “research team”?

The research team includes health care professionals such as doctors and nurses. Most studies have research coordinators, who are usually the first point of contact for the participant.

What is informed consent?

Informed consent is the process of learning about a clinical study before deciding whether or not to participate in it.  To help you decide, members of the research team explain the details of the study.  During this process you are encouraged to ask questions and to talk freely with the research team.  The research team will provide you with a consent form that includes details about the study such as its purpose, duration, required procedures, and key contacts.  Risks and potential benefits are also explained.  If you decide to participate in a study, you will be asked to sign the informed consent form.  The consent form needs to be signed before you can start the study.

What is a placebo?

A placebo is an inactive substance (e.g.,pill, liquid, or powder) that has no treatment value.  Placebos are more commonly known as “sugar pills.”  In many clinical trials, experimental treatments are compared with placebos to study whether or not the experimental treatment is effective.  In these studies, participants in one group (the control group) will receive a placebo instead of the active drug or treatment.

What are the benefits and risks of participating in a clinical trial?

Clinical trials may be beneficial to participants.  Well-designed and well-executed studies may allow participants to play a more active role in their own health care, gain access to new treatments before they are widely available, obtain expert medical care at leading health care facilities, and help others by contributing to medical research.

However, because clinical trials involve studying new medications or medical devices that are not yet approved, there may be side effects and other risks.  Some side effects are unpleasant, and they can be serious or even life-threatening.  The research team will review with the participant the known risks of study participation during the informed consent process and throughout the study. There is always the possibility that previously unknown risks could occur.