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For patients

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.

Our mission

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.

Glossary of terms:

 

A

  • Adverse drug reaction: An unintended reaction to a drug taken at normal doses.
  • Adverse event (AE): Any untoward medical occurrence in a study subject administrated a pharmaceutical product; it does not necessarily have to have a casual relationship with this treatment.

B

  • Beneficence: Doing no harm. Maximizing benefits while minimizing risks.
  • Biologic: A virus, toxin, antitoxin, blood product, therapeutic serum or similar material for the prevention, treatment or sure of disease or injury in humans.
  • Biotechnology: Any technique that uses living organisms or substances from living organisms, biological systems or processes to make or modify a product or process, to change plants or animals or to develop microorganisms for specific uses.
  • Blinding: The process through which study subjects, the investigator and/or other involved parties in a clinical trial are kept unaware of the treatment assignments of study subjects.

C

  • Case report form (CRF): A record of pertinent information collected on each subject during a clinical trial based on the protocol.
  • Certified clinical investigator (CCI): A clinical investigator who meets required experience and educational levels and has earned certification by passing an exam.
  • Certified clinical research coordinator (CCRC): CRC (Clinical Research Coordinator) with more than two years experience and certification earned by passing an exam.
  • Clinical trial (clinical study, clinical investigation): Any experiment that involves a test article (drug, device, biologic) and one or more human subjects.
  • Clinical research associate (CRA): The sponsor monitor who visits sites periodically during a study to monitor the data and assess progress.
  • Clinical research coordinator (CRC)(Study coordinator): The person at an investigational site who manages the daily operations of a clinical investigation and who is responsible to the investigator.
  • Clinical research organization (CRO): A person or entity that assumes, as an independent contractor with the sponsor, one or more of the obligations of the sponsor.
  • Control group: A group of subjects who are not treated with the investigational product. This group is used as a comparison to the treatment group.

D

  • Data management: The process of handling the data generated and collected during a clinical trial, ususally including data entry and database management.
  • Demographic data: The characteristics of study subjects, including age, sex, medical history and other information relevant to the study.
  • Device: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis, cure, treatment or prevention of disease. A device does not achieve its intended purpose through chemical action in the body and is not dependent upon being metabolized to achieve its purpose.
  • Double-blind: The design of a study in which neither the investigator nor the subject knows which treatment the subject is receiving.
  • Drug: An article (other than food) intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals.

E

  • Efficacy: A test product's ability to produce a beneficial effect on the duration or course of a disease.

F

  • FDA: The United States Food and Drug Administration.

G

  • Generic drug: A medicinal product with the same active ingredient(s) as a brand-name drug. Generic products may only be marketed after the original drug's patent has expired.
  • Good clinical practice (GCP): The regulations and guidelines that specify the responsibilities of sponsors, investigators, monitors and IRBs involved in clinical trials. They are meant to protect the safety, rights and welfare of the subjects in addition to ensuring the accuracy of the data collected during the trial.

H

  • Human subject: An individual who participates in research, either as a recipient of the test article or as a control. A subject may be either a healthy subject or a patient.

I

  • Inclusion and exclusion criteria: The characteristics that must be present (inclusion) or absent (exclusion) in order for a subject to qualify for a clinical trial, as per the protocol for the trial.
  • Informed consent: The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial.
  • Institutional review board (IRB): Any board, committee, or group formally designated to review biomedical research involving humans as subjects and to approve the initiation of and conduct periodic review of such research.
  • Investigator (clinical investigator [CI], principal investigator [PI]): An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is dispensed, or, in the case of an investigation conducted by a team of individuals, is the responsible leader of that team.
  • Investigator brochure: A compilation of all information known to date about the test product, including chemistry and formulation information and preclinical and clinical data. It is updated at least annually. Once the product is marketed, it is replaced by the labeling (package insert) for the product.
  • Investigational new drug: A new drug or biologic that is used in a clinical investigation.
  • Investigational new drug application (IND): The application to start clinical testing of a new drug, biologic or device in humans.
  • In vitro testing: Non-clinical testing conducted in an artificial environment, such as a test tube or culture medium.
  • In vivo testing: Testing conducted in living animal and human systems.
  • IRB approval: The determination of the IRB that the clinical investigation has been reviewed and may be conducted within the constraints set by the IRB and applicable regulations.

L

  • Legally authorized representative: An individual or judicial or other body authorized under applicable law to consent on behalf of a potential subject to the subject's participation in research.

M

  • Medical monitor (sponsor medical monitor): The physician at the sponsor who is responsible for the clinical investigation of a test product.
  • Minimal risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or in the performance of routine physical or psychological examinations or tests.

N

  • New drug application (NDA): The marketing application for a new drug submitted to the FDA. The NDA contains all the non-clinical, clinical, pharmacological, pharmacokinetic and stability data required by the FDA.

O

  • Open label study: A study in which the subjects and the investigator are aware of the drug that is being administered.

P

  • Placebo: An inactive substance designed to resemble the drug being tested.
  • Preclinical testing: Studies conducted on animals to determine that the drug is safe to use in studies on humans.
  • Protocol: The formal plan for carrying out a clinical investigation.

Q

  • Quality assurance: Systems and procedures designed to ensure that a study is being performed in accordance with Good Clinical Practice (GCP) guidelines and that the data being generated are accurate.

R

  • Randomization: A method in which study subjects are randomly assigned to treatment groups. It helps to reduce bias in a trial by ensuring that there is no pattern in the way subjects are assigned to treatment groups.

S

  • Serious adverse event (SAE): Any untoward medical occurrence at any dose that results in death, is life-threatening, requires hospitalization (or a prolongation of hospitalization in a patient who is already hospitalized), results in persistent or significant disability or incapacity or is a congenital anomaly/birth defect.
  • Site management organization (SMO): A group of investigational sites that have banded together and organized centrally to do studies.
  • Sponsor: The person or entity who initiates a clinical investigation but does not actually conduct the investigation.
  • Standard operating procedures (SOPs): Official written instructions for the management and conduct of clinical trial processes. SOPs ensure that processes carried out in a consistent and efficient manner.
  • Study coordinator (clinical research coordinator): The person at an investigational site who manages the daily operations of a clinical investigation and who is responsible to the investigator.
  • Sub-investigator: Any member of an investigational team other than the investigator.

T

  • Test article: Any drug, biologic or device being tested for use in humans.

U

  • Unanticipated event: Problem involving risks to human subjects or others participating in a clinical research study, e.g., breach of confidentially, incarceration of subject, suicide attempt or incorrect labeling of study drug. These, too, need to be collected and reported.