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Clinical Trials

Another aspect of treatment you may want to consider involves participation in clinical trials. Many advances in cancer diagnosis and treatment have grown out of research trials that enable doctors to evaluate the effectiveness of new treatments.

A clinical drug trial is a research study that tests an investigational new drug to see how safe it is and how well it works on people. The Food and Drug Administration (FDA) is the government agency responsible for overseeing the clinical trials process throughout the United States. You and your doctors will discuss if a clinical trial is appropriate for you.

There are four phases of clinical drug trials:

  • Phase I: A phase I trial tests the safety and determines the side effects of the new drug. Increasing amounts of the drug are given to small groups of patients to see how people react to the drug. Phase I trials are not meant to determine the ability of the drug to treat the patients disease. It is possible that the experimental drug may help the disease but it is also possible that it will not or even be harmful. A Phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
  • Phase II: After the successful completion of phase I trials, the drug is then tested in a larger population of individuals who are afflicted with the disease for which the drug was developed. Phase II trials determine the ability of the drug to treat the disease and to better understand the drugs side effects.
  • Phase III: A phase III trial is where the new treatment is compared with results of people taking standard treatment, for example, which group has better survival rates or fewer side effects.
  • Phase IV: After the U.S. Food and Drug Administration (FDA) has approved a drug, phase IV studies are conducted to compare the drug to a competitor, explore the use of the drug in other conditions, or to further study any side effects.

Penn’s Neuro-oncology Program focuses on phase I and phase II clinical trials for patients with brain tumors. At times, phase III studies may be available. The Neuro-oncology program is a member of the New Approaches to Brain Tumor Therapy (NABTT): A CNS Consortium. NABTT is one of two consortia funded by the National Institutes of Health (NIH) that are dedicated to carrying out clinical trials of promising new drugs for patients with brain tumors.

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