Dr. Susan Love Research Foundation | Breast Cancer

Clinical trials are critical to the development of new cancer treatments. Without clinical trials, there would be no way to determine if new treatments are safe and effective, what risks or side effects they have, and whether they are equivalent to or superior than treatments already in use. Because new trials are getting underway all the time, oncologists (doctors who specialize in treating cancer) are not always aware of all the trials open to their patients. This means that cancer patients frequently must do their own research to find the clinical trials that may be right for them.

Clinical trials are divided into four phases:
Phase I: Researchers test a new drug or treatment to determine its safety, to assess what dosage is best, and to identify side effects. These studies usually only enroll a very small number of people.

Phase II: Researchers look at whether the drug or treatment is effective. They also assess safety and side effects. These trials generally involve fewer than 100 people.

Phase III:Researchers compare the new drug or treatment with the standard treatment to determine which is more effective and which has more side effects. These trials often include hundreds or thousands of people. New treatments need to do well in Phase III studies to receive approval from the US Food and Drug Administration (FDA).

Phase IV: These trials are conducted after a drug has received FDA approval to assess any side effects associated with long-term use.

Before you begin searching for a clinical trial, you must know what size tumor you have and your cancer's stage. You should look for a trial before you have surgery, radiation, chemotherapy, or hormone therapy.

If you find a trial that interests you, contact the study coordinator. The coordinator will work with you to determine if you are eligible for the trial. You should also talk to your doctor about the study you are interested in. If your doctor does not think the trial is right for you, find out why. You can discuss your doctor's concerns with the study coordinator. You may also want to get a second opinion from another oncologist. You should also talk to the study coordinator about what the trial will cover and what may be required of your health insurance company.

What Did the Study Find? Access to Clinical Trials Data Increases
In September 2004, the International Committee of Medical Journal Editors (ICMJE) — a group of editors who hail from what are widely considered the most important medical journals — simultaneously published editorials calling for the development of a comprehensive clinical trials registration database. Further, the editors announced that "all 11 ICMJE member journals will adopt a trials-registration policy to promote this goal." Under this new policy, for a paper to be considered for publication in these journals, the trial it describes must have been registered previously in a public trials registry. Free access to the findings of all clinical trials—not just the ones that have been published—will provide women with a more comprehensive understanding of what the treatments they are taking can do, how they compare to other similar treatments, and what their full range of risks and side effects are.

Susan says:
I've been an advocate of the need for a mandatory clinical trials database for some time. I strongly feel that it is important for all publicly funded research results to be available to the public. Research should be a partnership between scientists and the participants, and the data should be available to both.