Clinical trials offer access to the latest treatment options
If you have heart or vascular disease, you want access to the latest, most advanced care. We are dedicated to providing the latest treatment options to patients in our community through participating in routine research trials.
Novant Health is a leader in national and international heart and vascular research. We are dedicated to providing the latest treatment options to our patients; we participate in many drug and device research trials. This ensures that you and your loved ones can get the latest heart and vascular treatments – close to home. We are continually involved in studies of new drugs, interventional procedures, surgical procedures and other medical devices, and we have been the top enroller statewide, nationally and internationally for numerous trials.
The Novant Health Heart and Vascular Institute Division of Research will participate in clinically-relevant medical research for the advancement of medical science and the benefit of our patients.
The Novant Health Heart and Vascular Institute will only participate in the clinical protocols that meet our standards for ethics, safety, and scientific relevance. We will prioritize trials that seek to answer crucial clinical questions, provide our patients with advanced medical technology not otherwise attainable, or potentially lessen the financial burden of their medical care. We recognize that our participation in clinical research is one means of continuing to maintain our physicians in positions of leadership in the medical community and, in so doing, ultimately improves our ability to care for our patients.
We have these current clinical trials:
- Acute coronary syndrome
- Cardiac dysrhythmias
- Congestive heart failure
- Coronary artery disease
- Interventional treatments
- Peripheral arterial disease
Frequently asked questions
Here are some of the most common questions about clinical trials and research:
What is a clinical trial?
A clinical trial (or clinical research) is a research study of human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
What are the benefits and risks of participating in a clinical trial?
Benefits – If you are an eligible participant, clinical trials that are well-designed and well-executed are the best approach for you to:
- Play an active role in your own healthcare.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading healthcare facilities during the trial.
- Help others by contributing to medical research.
Risks – There are risks to clinical trials:
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
- The experimental treatment may not be effective for you.
- The protocol may require more of your time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other healthcare professionals. They check your health at the beginning of the trial, give specific instructions for participating in the trial, monitor your health carefully during the trial and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than you would normally have for an illness or condition. For all types of trials, you work with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
How is your safety protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect you. The trial follows a carefully-controlled protocol, a study plan that details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.
What should you consider before participating in a trial?
You should know as much as possible about the clinical trial and feel comfortable asking the members of the healthcare team questions about it, the care expected while in a trial and the cost of the trial. The following questions might be helpful for you to discuss with the healthcare team. Some of the answers to these questions are found in the informed consent document.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
Clinical trial phases
Phase I trials
These first studies evaluate how a new treatment should be administered (orally, intravenously, by injection, inhalation, etc.), how often and in what dosage. The primary objective of a Phase I trial is to define the proper dosing and identify side effects. A Phase I trial usually enrolls only a small number of patients.
Phase II trials
A Phase II trial provides preliminary information about how well the new treatment works and generates more information about safety and benefit. The goal of Phase II studies is to determine the common short-term side effects and risks (if any) associated with a new drug.
Phase III trials
These trials compare a promising new drug, combination of drugs or procedure with the current standard therapy. Phase III trials typically involve large numbers of patients from doctors’ offices, clinics and centers nationwide. The reason that the Phase III clinical trial has been initiated is that the superiority of one treatment over the other has not yet been firmly established.
If you participate in a Phase III treatment trial, you are likely to be randomized (assigned by chance) to a group receiving either the new intervention or the standard intervention. Neither you nor your physician chooses whether you get the new intervention or the standard treatment.
Trials designed in this way are also called randomized controlled trials. If you are assigned the standard intervention, you receive what experts view as the best treatment available. Experts believe that each treatment is effective but really don’t know which one is better. If you are assigned the new intervention, you receive a treatment that some experts think may have some advantages over the standard.
Phase IV trials
Some use the term Phase IV to include the continuing evaluation that takes place after FDA approval, when the drug or treatment procedure is already on the market and available for general use. This is also called a post-marketing surveillance study.