FAQ about clinical research

A clinical trial is a research study carefully designed to answer specific questions about vaccines, new medications or new ways of using known medications. Clinical trials measure the medication's ability to treat a medical condition and how safe it is to use. The FDA (U.S. Food and Drug Administration) has strict rules by which all clinical trials must be conducted. The FDA then looks at the results of the studies to decide whether to approve them for use by the general public.

In order to be FDA-approved for patient use, all new medicines must go through the clinical research process and be able to demonstrate their safety and effectiveness. Virginia Women's Center is compensated by the study's sponsors for the care that we provide to our research patients. Our compensation is not based on the outcomes of the studies.

All clinical trials have guidelines about who can participate in the program. Guidelines are based on factors such as age, health condition, medical history and current medical condition. Before you join a clinical study, you must qualify for the study. The study physician reviews each volunteer's medical history to determine who can participate. Please note that the guidelines for the study, also known as inclusion/exclusion criteria, are not used to reject people personally, but to identify appropriate volunteers and keep them safe.

Every year, millions of people volunteer for clinical studies. They participate for reasons such as:

• They may learn more about their medical condition.
• They may gain access to treatments that are not available to the public.
• They want expert medical care (physical exams, diagnostic tests, lab tests and physician advice) at leading health care facilities, which is often available at no cost.
• They may want to help in discovering new medicines or treatments for themselves, family members and their community.

In addition to the providers and staff at Virginia Women's Center, the research sponsor and the FDA, U.S. law requires that an ethics committee (called an Institutional Review Board, IRB) look out for your interests. The IRB consists of a group of independent healthcare professionals and community members chartered to protect the safety and rights of research volunteers. IRBs must approve clinical studies before they begin. They also monitor studies as they proceed.

There are both benefits and risks associated with clinical trials. By participating in a clinical trial, you can:

• Take an active role in your own health care.
• Gain access to new treatments that are not available to the public.
• Obtain expert medical care at leading healthcare facilities during the trial.
• Help others by contributing to medical research.

Clinical trials have risks:

• There may be side effects or adverse reactions to medications or treatments.
• The treatment may not be effective for you.
• The protocol may require a lot of your time for trips to the study site, treatments, hospital stays or complex dosage requirements.

Some clinical trials will pay you for joining the trial, while others will not. In some programs, researchers will reimburse you for expenses associated with participating in the research. Such expenses may include transportation costs, child care, meals and accomodation.

Here are some additional questions that we recommend you consider before participating in a clinical trial:

• Why is this research being done?
• What is the purpose of the study?
• Where is the study site?
• What kinds of therapies, procedures and/or tests will I have during the trial?
• Will there be pain? If so, for how long?
• How will the test in the study compare to tests I would have outside of the study?
• How long will the study last?
• How often will I have to go to the study site?
• Who will provide my medical care after the study ends?
• Will I be able to take my regular medications during the trial?
• What medications, procedures or treatments must I avoid while in the study?
• What are my responsibilities during the study?
• Will I have to be in the hospital at all?
• Will the trial researchers work with my doctor during the trial?

In order to participate in a clinical study, you must be fully informed about the study and give your consent to participate. You must understand the study procedures, potential risks and benefits as well as your responsibilities as a study participant. You are encouraged to ask questions and share this information with your family, friends and doctor.

You can view more information about the clinical research studies that are currently enrolling at Virginia Women's Center. Contact a clinical research coordinator at 804.662.6117 or send a secure message on our patient portal to learn more or express interest in participating in one of our current studies.