Clinical Trials

Clinical trials help find new ways to treat diseases. They test methods to find, prevent, diagnose, or treat cancer.1 Trials may offer screening and even treatment that some people may not have access to.

Types of Clinical Trials

These are the four types of clinical trials in cancer research:

Prevention trials:
Prevention trials explore ways to help lower the risk of getting cancer. They also look at ways to keep cancer from coming back in people who did have the disease, or from moving to another part of the body.2
Screening trials:
Screening trials test ways to find cancer early.2
Treatment trials:
Treatment trials test new types of treatments or new ways of using current treatments. This might include a new cancer drug or a new kind of surgery or radiation. Trials also might look at a combination of these treatments.2
Quality of life trials:
Quality of life trials help to find ways to improve quality of life and comfort for cancer patients.2 They are also called supportive care trials.

Clinical Trial Phases

Trials are made up of many steps.2 This process helps find out if a new treatment works and is safe. It also helps find if a new tool to screen for cancer is correct. Each step lets doctors ask questions that protect patients, while finding answers and details about the drug.

The development of new drugs usually involves four phases:

Phase I:
Phase I helps determine how a new cancer treatment or drug should be given, such as how often the drug should be given and what dose is safe. They often involve only a relatively small number of patients.3
Phase II:
In Phase II, a new cancer treatment or drug is studied to find out if it works and is safe in people.2 These trials often help to determine the types of patients who respond best or have adverse side effects and the dosage schedule of the drug that works best.
Phase III:
Phase III further tests if a new cancer treatment, a previously approved treatment, or a new combination of cancer treatments are safe and how well they work. People in the trial may be assigned at random (by chance) to either receive the new treatment, the current standard of care or sometimes a placebo (sugar pill) to see which one works better. This is called randomization. Phase III studies tend to look at a large number of people from many places across the country or around the world.
Phase IV:
Phase IV trials are performed to provide additional data on the use and safety of a cancer treatment after it has been approved by the Food and Drug Administration (FDA).2

Taking part in a clinical trial may not be right for everyone. You may want to talk to your doctor to see if there are any trials for your cancer type, and whether being in a trial is right for you.

References:
  1. National Cancer Institute. Dictionary of Cancer Terms: Clinical Trials. Available at http://www.cancer.gov/dictionary?cdrid=45961. Accessed April 1, 2011.
  2. National Cancer Institute. Cancer Clinical Trials. Available at http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials. Accessed April 1, 2011.
  3. National Cancer Institute. Dictionary of Cancer Terms: Phase I Trial. Available at http://www.cancer.gov/dictionary?CdrID=45830. Accessed April 15, 2011.

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