What is a Clinical Trial?

A clinical trial is a research study involving people who volunteer to participate. It is one of the final stages of medical research necessary to evaluate promising new approaches to cancer prevention, diagnosis and treatment. Clinical trials most often investigate new drugs or combinations of drugs, as well as drug doses and schedules.  They also investigate new diagnostic and screening tests, surgical and radiation therapy procedures, behavioral (e.g., diet or exercise), psychosocial (e.g., counseling) interventions and rehabilitation issues.

When you join a clinical trial, you receive a new drug and/or procedure or the current standard of care. Researchers then evaluate the effect of the new treatment and compare it to the standard treatment. New findings can play a significant role in shaping the future of cancer treatment and advancing the overall level of care available.

Less than 6% of breast cancer patients are in clinical trials. Without a sufficient number of participants, a clinical trial could be held up for months, if not years, delaying the possibility of a breakthrough. By enrolling in a clinical trial, you not only help yourself, but you also help millions of breast cancer patients around the world who may benefit from your participation.

Potential Benefits

A well-designed clinical trial can offer patients:

• Access to promising therapy and drugs not yet available to the public.

• Treatment provided by leading physicians.

• Careful monitoring of your cancer and treatment

• The ability to take a more active role in your own health care.

• An opportunity to help others by contributing to medical research.

Potential Disadvantages

Patients should consider the possible down side of clinical trials:

• You will be randomly assigned to treatment.

• Investigational therapies may have unexpected side effects.

• Additional tests or clinic visits may be required for research, rather than for treatment purposes.

• Incremental costs that are not covered by insurance or by the researcher may be involved.

October 2007