Clinical trials are vital in studying all aspects of medicine, not just cancer. The stakes may seem higher when researching medicines to treat cancer, but all new treatments (drugs and medical devices) must go through clinical trials before being approved by the FDA.
Fact: All clinical trials are voluntary.
You always have the right to choose whether or not you will take part in a clinical trial for which you meet the criteria. The level of care you get should not be affected by your decision. And you have the right to leave a clinical trial at any time, for any reason. If you decide to leave the study, talk to your doctor first. You will want to know how quitting the study might affect your health and what other treatment options you have. You should also tell the research group that you are quitting and why. Your health care team may ask that you agree to continue to be watched for a certain length of time to look for any long-term effects of treatment. We discuss these issues further in "What would taking part in a clinical trial involve?" in the section "What protects the study participants?"
Fact: Not all clinical trials study treatments.
Even though we talk about research studies as if they are all about treatments, many clinical trials look at new ways to detect, diagnose, or learn the extent of disease. Some even look at ways to prevent the disease from happening in the first place.
Fact: Even among clinical trials that do study treatments, not all of them study drugs.
Many clinical trials test other forms of treatment, such as new surgery or radiation therapy techniques, or even complementary or alternative medicines or techniques.
Fact: When clinical trials do look at drugs, not all of them study new ones.
Even after a drug has been approved for use against a type of cancer, doctors sometimes find it works better when given a certain way or when combined with other treatments. It may even work on a different cancer. Clinical trials are needed to study these possibilities as well.
Fact: Very few cancer clinical trials involve a placebo.
A placebo is a fake treatment, inactive ingredient, or sham pill used in some types of clinical trials to help make sure results are unbiased. A placebo is sometimes called a "sugar pill." Over the years, doctors have observed that some people begin to feel better even if they just think they're being treated. Although this effect tends to be brief, and does not really affect a cancer, it can make a new treatment seem to help. The possibility of getting a placebo keeps people from knowing if they are getting the treatment being studied or not, which makes the results more likely to be valid.
Placebos are rarely used alone in cancer research unless no known effective treatments exist. It's certainly not ethical to have someone take a placebo if an effective standard treatment is already available. When cancer clinical trials compare treatments, they compare the new treatment against the current standard treatment. At times, a study may be designed so that patients may not be told which one they are getting, but they know they are at the very least getting treatment that meets the current standard of care.
In some clinical trials, the doctors want to learn if adding a new drug to the standard therapy makes it work better. In these studies, some patients get the standard drug(s) and the new one being tested, while other patients get the standard drug(s) and a placebo. But none of the patients would get only a placebo. Everyone gets standard treatment if there is a standard treatment available. (See the next section for an example of a phase III study that uses a placebo.) For more information about placebos and how they are used in some studies, see our document called Placebo Effect.
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