Clinical Trials

Another treatment option available to some patients is to participate in a study of a new cancer treatment. Every successful cancer treatment being used today was first tested in a clinical trial, a three-step research process designed to evaluate the safety and effectiveness of new treatments for diseases. Clinical trials are conducted at the end of a much longer process of developing and testing new therapies in the laboratory. Patients who participate in successful trials are the first to benefit from the new therapy.

Doctors in many hospitals and cancer centers across the country conduct clinical trials as new drugs and other therapies become available for treating cancer patients. Each carefully planned study is designed to answer certain questions and to find out specific information about how well a new drug or treatment method works.

All new treatments must go through three steps or phases of clinical trials:

  • Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and in what dose. A Phase I trial usually involves only a small number of patients, sometimes as few as a dozen.

  • Phase II trials: A Phase II trial continues to test the safety of the drug and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.

  • Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard for treatment. A participant will usually be assigned to the standard treatment group or the new treatment group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.

All clinical trial participants receive the best care possible, and their reactions to the treatment are watched very closely. If the treatment does not seem to be helping, a doctor can take a patient out of a study. A patient may choose to leave a trial at any time. If a patient leaves a research study for any reason, standard care and treatment are still available.

Clinical Trials at The University of Maryland Marlene and Stewart Greenebaum Cancer Center

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