Understanding Clinical Trials

If you are interested in enrolling in a clinical trial, talk to your doctor about what may be right for you. Below you will find some background information about clinical trials that may help inform your discussion with your doctor.

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A clinical trial is a carefully designed research study in which people participate as volunteers to test new methods of screening, preventing, diagnosing, or treating breast cancer. Clinical trials are also referred to as clinical studies, medical research, and research protocols. Carefully conducted clinical trials are the safest and most effective way to find new methods of preventing, diagnosing, and treating breast cancer.

Clinical trials are a very regulated process. Clinical trials for new cancer treatments only get underway after there is evidence from laboratory studies (first in cells and then in animals like mice) that the treatment appears to work. The US Food and Drug Administration uses clinical trial findings, which report safety and effectiveness, to determine whether new treatments should be approved and integrated into routine care.

There are also opportunities to be in studies to help scientists learn about who is going to develop what kind of cancer. These are called observational studies and do not involve any type of experimental drug or intervention. Instead, study participants are observed over time. The Sister Study, for example, is a long-term observational study of women whose sister(s) had breast cancer that is investigating environmental and genetic factors that affect a woman's chances of getting breast cancer.

In the future, care delivered through the process of screening and breast cancer treatment should be integrated with the ability to better educate our patients about all of their risk factors and options, and to make sure we have the opportunity to constantly improve what we do—FASTER!