Am I Eligible for a Clinical Trial?

Based on the questions the research is trying to answer, each clinical trial protocol clearly states who can or cannot join the trial.

Common Criteria for Entering a Trial

• Having a certain type or stage of cancer
• Having received a certain kind of therapy in the past
• Being in a certain age group

Criteria such as these help ensure that people in the trial are as alike as possible. This way doctors can be sure that the results are due to the treatment being studied and not other factors.

These criteria also help ensure:

• Safety: Some people have health problems besides cancer that could be made worse by the treatments in a study. If you are interested in joining a trial, you will receive medical tests to be sure that you are not put at increased risk.
• Accurate and meaningful study results: You may not be able to join some clinical trials if you already have had another kind of treatment for your cancer. Otherwise, doctors could not be sure whether your results were due to the treatment being studied or the earlier treatment.

Randomization

Randomization is a process used in some clinical trials to prevent bias. Bias occurs when a trial's results are affected by human choices or other factors not related to the treatments being tested. Randomization helps ensure that unknown factors do not affect trial results.

If you participate in such a trial, you will be assigned by chance to either an investigational group or a control group. Your assignment will be determined with a computer program or table of random numbers.

• If you are assigned to the control group, you will get the most widely accepted treatment (standard treatment) for your cancer.
• If you are assigned to the investigational group, you will get the new treatment being tested.

Comparing these groups to each other often clearly shows which treatment is more effective or has fewer side effects. If you are thinking about joining a randomized clinical trial, you need to understand that there is an equal chance you will be assigned to either group. Neither you nor the doctor chooses the group you will be in.

Will I Get a Placebo?

A placebo is designed to look like the medicine being tested, but it is not active. Placebos are almost never used in cancer treatment trials. In some cases, a study may compare standard treatment plus a new treatment, to standard treatment plus a placebo. You will be told if the study uses a placebo.

Federal rules help ensure that clinical trials are run in an ethical manner.

Whenever you need treatment for your cancer, clinical trials may be an option for you. Choosing to join a clinical trial is something only you, those close to you, and your doctors and nurses can decide together.