FAQ

Answering your questions about clinical research participation at WakeMed.

Why is WakeMed participating in clinical research?

As a regional leader in health care, WakeMed has always been committed to improving care and innovation. It’s part of our mission and values. By working with respected Clinical Research Organizations (CRO) that are conducting meaningful studies, we are fulfilling an important role in the future of medicine. We have continually sought ways to improve health care and by becoming a study site, we believe it will benefit patients here at home and beyond.

What is clinical research, and how is it beneficial?

Clinical research, often referred to as a clinical trial, is a regulated study that helps determines the safety and efficacy of a new drug, procedure or medical device. These studies require a sample of participants who volunteer their time during the course of the study.

Most studies look at particular disease states or medical conditions to see if the therapy/device is more beneficial in prevention or treatment of the problem. All participants are volunteers and must adhere to the study guidelines. Each volunteer signs a voluntary consent form that outlines the benefits and risks of their participation and the details of the study. Participants may opt to leave a study at any time for any reason.

What are the main benefits for participating in a clinical study?

Most people decide to sign up for a study because they need additional help with a medical condition or access to an alternative treatment to improve their quality of life. By doing so, their participation will provide critical information about a new medicine, treatment or medical device that could potentially help thousands of people living with the same condition.

Not all studies include the same benefits, but most include:

Free exams and ongoing medical assessments and diagnostic testing Study drugs/medical devices at no cost Financial compensation/travel reimbursement

What are the risks for participating a clinical study?

While each study is unique, all studies carry benefits and risks. It’s important to fully understand the details of the study. All clinical trials are submitted to an Institutional Review Board (IRB), which reviews each study in advance for safety. With any medical treatment, medication or medical device, there can be risks. These will be reviewed with you in detail prior to your participation.

When you join a study are you are assuming these risks, but you may drop out of a study at any time. To find out more about clinical research studies, please feel free to call us. We will gladly answer any questions or concerns that you may have.

What do I need to know before committing to a clinical study?

Before you sign up for a study, you will have to qualify for the study and acknowledge that you understand the details of the study – including the benefits (medications, treatments, medical devices, financial compensation, etc.) and risks. This will be explained to you in detail, and you will have a contact who can answer your questions. Your participation is strictly voluntary. Please know that you can leave the study at any time. You are under no obligation.

I have some concerns about how my rights are protected. What guarantees do I have as a participant?

WakeMed partners only with Clinical Research Organizations (CRO) and Sponsors that operate using the strictest safety standards and meet all federal government guidelines that govern human research. The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) oversee research studies to assure safety of volunteers.

Additionally, an Institutional Review Board (IRB), which is comprised of physicians, scientists and other health, business and community leaders, approves all clinical research studies.

Our WakeMed physician investigators who lead our participation in studies are certified in industry recognized Good Clinical Practice (GCP) training and can provide complete information about the study benefits and risks.

Before joining a study, you will receive written information that outlines the benefits and risks. You will sign a consent form that confirms that you understand the details of the clinical study.

Are there any costs associated with a clinical research trial or will I be paid for my participation?

In most cases, participants are paid a small fee and reimbursed for travel expenses. Any medical exams, ongoing assessments and drugs/medical devices will be supplied at no cost to the participant. However, each study is different and will be explained to you in detail before your sign up for a new study.

How do I find current study opportunities at WakeMed?

For more information on clinical research studies available at WakeMed Clinical Research Institute, please contact: Diana Rhyne (Director of Clinical Research) at DiRhyne@wakemed.org or Dr. Bill Lagarde (Medical Director) at BLagarde@wakemed.org