Breast Cancer 101

A Guide to Breast Cancer by Susan G. Komen

Enrolling in a Clinical Trial

Transcript

Informed consent is the process of reviewing the purpose, risks, benefits and options for the study. It’s required for all clinical trials.

If you’re considering joining a clinical trial, a study coordinator or nurse will review the study protocol in detail with you and answer any questions you have.

The protocol describes the reason for the study, the study design, the treatment regimen, what tests will be done and how often they will be done, what data will be collected, how many people will be in the study and eligibility criteria.

If you decide to join the study, you’ll be asked for your written permission. The document you sign is called a consent form. You will get a copy for your records. This form includes the study protocol as well as the potential risks and benefits of the treatment or test. Since joining a clinical trial is completely voluntary, you can leave at any time for any reason. Signing a consent form does not require you to stay in a study.

Trials are conducted at sites around the world, but certain trials may be limited to specific locations. They are sponsored by government agencies, non-profit organizations, and pharmaceutical and biotechnology companies.

Some trials are funded by a single agency like the National Cancer Institute and are done at the same time in many sites across the country. These are called cooperative group clinical trials and allow researchers to increase the number of people in a given study.

Information about clinical trials is available from a number of sources. One of the most comprehensive lists of current clinical trials is found on the National Institutes of Health website at www.clinicaltrials.gov.

BreastCancerTrials.org in collaboration with Susan G. Komen offers a custom matching service that can help people find clinical trials that fit their needs.

Access to these resources and more information about clinical trials is available on the Clinical Trials page of the Susan G. Komen website at www.komen.org.

If you or a loved one needs information or resources about clinical trials, call the Komen Breast Care Helpline at 1-877 GO KOMEN (1-877- 465- 6636) or email clinicaltrialinfo@komen.org.