What is a clinical trial?

In health care, a clinical trial or research study is done to determine the safety and effectiveness of an investigational drug or other therapy, often compared to what is already on the market. Sometimes we study a medication approved for one condition to see if it helps a different condition.

Why should I volunteer?

There are many reasons why people choose to participate in a study. A few are listed below:

• To obtain access to investigational drugs that are otherwise unavailable to the public.
• To help researchers learn more about health and disease, and possibly improve the health of others.
• To learn more about your health condition from medical professionals dedicated to clinical research.

Who can participate?

Participation is based on meeting specific conditions, called "Eligibility Criteria". Every study has detailed criteria specifying the age, sex, and physical or health conditions that must be met for qualification. Your participation in a research study will include a careful screening evaluation to make sure you meet these requirements.

Are clinical trials safe?

Every medication, approved or investigational, has potential side effects; however, the side effects of investigational drugs may be largely or completely unknown. Some people may react to a medication more than others, such as an allergic reaction. An important aspect of participation in a clinical trial is the frequency of visits to the study offices to meet with the study doctor and to check for possible side effects. All medications used in clinical trails have been previously tested in animals before human trials can begin, but some side effects may not be known until they are tested in humans.

What happens during the study?

Each clinical trial has a specific study plan. All clinical studies begin with an informed consent process when the potential participant reads a document (the Informed Consent) that explains all study procedures, risks and potential benefits. The potential participant and the study doctor will discuss the study, all procedures and what is currently known about the study medications. No study procedures will be completed until the participant fully understands the trial, has had all questions answered, and agrees to participate. The study procedures usually involve multiple visits to the study offices and general medical procedures such as a brief physical examination, an ECG and/or blood draw. The study Informed Consent contains detailed information about the procedures required for a specific study.

If I am interested, what is the next step?

Learn about Genova's current studies and fill out the participant interest form if you'd like to become a volunteer. The Patient Recruiter at Genova will contact you and explain the study, go over required procedures and determine if you may be eligible. She will schedule an appointment for you to meet with the study doctor.