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Understanding what clinical trials are all about

If you have been diagnosed with cancer it is important to understand what a clinical trial is and also where you can find out information on how to get into one. Clinical trials must be done before a new treatment is approved by the US Food and Drug Administration (FDA).

There are different types or phases of clinical trials. Each phase is designed to find out different information. Each new phase of a clinical trial depends on and builds on information from an earlier phase.

  • Phase I clinical trials are to find out the best way to give a new treatment and how much of it can be given safely. Researchers will closely monitor the patient's side effects and adjust the dosage as needed. This phase is usually only tested on a small amount of participants. Phase I trials can have significant risks associated with them for the patient because the drug or new treatment regimen has been studied in the lab but not on humans. The research in the lab cannot identify all the side effects that might occur. Phase I trials are usually only offered to those who's cancer cannot be helped by other known treatments available.
  • Phase II clinical trials attempt to determine a patient's response to treatments. Patients are closely monitored to see if the new treatment controls the cancer or shrinks it. Side effects are also assessed at this phase because the trial involves more people so they can see a larger group and how they react to the new treatment.
  • Phase III clinical trials look for longer life, better quality of life, fewer side effects and fewer cases of the cancer returning. These trials enroll a large number of patients (sometimes thousands). The patients are usually divided into two groups. One group will receive the standard therapy available for their type of cancer and the other group will get the new treatment. Patients are usually assigned by chance for the two separate groups being studied.

Cancer patients do not have to just count on trial information from their physicians. The patient can directly investigate their own eligibility for a clinical trial by calling the Cancer Information Service at 1-800-4-CANCER. Another valuable resource for patients to find out about clinical trials is the website www.clinicaltrial.gov.

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