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What is a Clinical Trial?

Clinical studies are biomedical or health-related investigations in human beings or animals that attempt to answer a question in a systematic way.  As such, they often are used to evaluate risk factors for disease, as well as methods to prevent, treat or cure disease.  A clinical trial is one type of clinical study that involves testing the effects of a new or existing treatment on an illness or disorder.  The treatment can be a drug, a biological agent, a medical device, or a behavioral change.

Why are Clinical Trials important?

Extensive laboratory research precedes the initiation of a clinical trial. The treatment in question will have been evaluated in a laboratory setting and promising results obtained that support its further evaluation in a clinical trial. As laboratory investigations cannot accurately predict how an individual with naturally occurring disease will respond to the treatment, a clinical trial must be performed to identify how safe and effective a treatment is for its intended use. Many clinical trials in the veterinary field involve treatments that have already been proven safe and effective in humans with similar disease. However, since animals differ from humans in many ways – including how they may respond to specific treatment – veterinary based clinical trials are needed to determine the most appropriate treatment for our pets.

What are the benefits of participating in a clinical trial

Participation in a clinical trial allows the patient to gain access to new research treatments before they are widely available as well as obtain expert veterinary medical care during the trial. In addition, there may be financial incentives for enrolling in a clinical trial, including free veterinary care, testing and treatment. Participants in clinical trials are also helping others by contributing to the advancement of medical research.

Are there risks of participating in a clinical trial?

The experimental treatment may not be effective for the participant, and may be associated with side effects. In addition, participation in a clinical trial may involve multiple visits to the study site for treatment and follow-up; more so than if the patient were not involved in a clinical trial. The specific requirements of each study as well as potential study associated risks are detailed in the Informed Consent document. This document must be signed prior to participation in a clinical trial. However, informed consent is not a contract, and the participant may withdraw from the trial at any time. To help ensure the safety of study participants, all clinical trials performed at the Veterinary Teaching Hospital must be approved by the Institutional Animal Care and Use Committee (IACUC) at North Carolina State University.

Where does financial support come from?

The College's research activities are supported by a variety of means. The state of North Carolina provides base support for the research programs, but most research activity is funded through competitive grants from national agencies such as the National Institutes of Health as well as agencies devoted solely to animal health and welfare, and through grants, contracts or memoranda of agreement with private companies, foundations and other agencies.