The Preston Robert Tisch Brain Tumor Center at Duke

Clinical Trials Frequently Asked Questions

    What is a clinical trial?
  • A clinical trial is a research study. It may be looking at a new drug, a new medical device, or a new combination of drugs and/or treatments. Clinical trials are developed after laboratory research on animals is completed. Participation in a clinical trial is voluntary.

    What is a protocol?
  • A protocol is the written plan of the clinical trial. It describes the details of the study, such as who can participate, what tests will be done and how often, what the risks are, what the benefits of participating include, etc.

    Are there risks involved in participating in clinical trials?
  • With any new treatments, there may be risks as well as benefits. These risks will be discussed in detail as part of the informed consent. Because of the potential risks, a team of doctors, nurses, clinical research coordinators, and researchers carefully monitor clinical trials.

    What are phases of a clinical trial?
  • Clinical trials include different phases. Each phase is designed to find out specific information that allows the trial to continue to the next phase.
  • Phase I trials test the drug or device on humans for the first time. These trials are based on animal laboratory studies. They are looking for the maximum amount of drug that can be given to a human. Phase I studies also look at the side effects or toxicity of the drug. Small numbers of patients are usually treated on Phase I trials.
  • Phase II trials look at side effects of a drug or device based on the maximum tolerated dose determined by the Phase I study. Larger numbers of patients are treated on Phase II studies.
  • Phase III trials compare the results of the new treatment with results of standard treatments to see if it is more effective. In most cases, studies move into Phase III after a treatment shows promise in Phases I and II.
  • Phase IV trials are postmarking studies that are generally done to look at other possible uses for the drug or treatment. They are initiated after approval from the Food and Drug Administration is sought and the drug or treatment has become commercially available.

    Why would a patient decide to be part of a clinical trial?
  • A patient may decide to participate for any number of reasons, including hope for a cure, increasing longevity, feeling better on a daily basis, or for the desire to contribute to research to benefit future generations.

If you have further questions about how clinical trials work, ask your doctor, nurse, or other healthcare professional.

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