Research studies give you access to new treatment options
Volunteers help make it possible for new drugs and therapies to become available for treating illnesses. The U.S. Food and Drug Administration (FDA) requires testing in clinical research studies involving humans before new drugs and devices can be available to the public. This makes volunteers essential to the approval process. The information available here can help you understand how volunteers participate in research.
What is a clinical trial?
Clinical trials are research studies designed to answer specific scientific questions and find effective solutions for preventing, diagnosing or treating a disorder or disease.
What happens during a clinical trial?
The process depends on the type of study being conducted. Trials vary in length. Some studies may last a few weeks; others may last months or years. Our research teams work closely with volunteers so that they understand the required time investments and other aspects of the study before they agree to participate.
When someone chooses to participate in a clinical trial, the medical care they receive during the study is much like the care they would get otherwise. However, there is often additional monitoring to learn about potential side effects and benefits of the therapy being tested. Some trials study new drugs or devices or a combination therapy. Throughout the trial, the volunteer’s physician and the research team monitor the participant closely.
How will I be protected?
Novant Health clinical research is governed by, and fully compliant with, regulations from the FDA and other regulatory bodies. Furthermore, our clinical research team consists of physicians, nurses, social workers and other healthcare professionals who work to ensure you have a comfortable experience.
What are my responsibilities in a clinical trial?
Each clinical trial is different, so it is important to ask questions if you are a candidate. We want volunteers to be as well-informed as possible leading up to participation. Basic pretrial questions include:
- What is this research about?
- How does this research help the treatment of my disorder?
- Why am I an ideal candidate?
- How does participating in this trial benefit me?
- What are the possible risks this research poses to my health?
- How will this trial differ from the treatment I am already receiving?
- What happens at the end of this study?
- How much of my time will this research trial require?
- What happens if I no longer want to participate?
Should I participate in a clinical trial?
Participation is a highly personal decision. Your healthcare team can help you determine whether a clinical trial is right for you. We encourage you to also talk with your family and loved ones before deciding. The outcome of clinical trials cannot be guaranteed, and therapies being tested may have side effects. You will be informed of these risks as much as possible, and your healthcare team will give you the information you need to make a decision that is right for you.