Participating in Clinical Trials

What Are Clinical Trials?

The main purpose of a clinical trial is to determine if a drug (or a procedure) is a safe and effective treatment for a medical condition, such as breast cancer.

All clinical trials must follow strict standards of regulatory authorities regarding data collection, treatment, and safety.

How Are Clinical Trials Conducted?

• Patients who qualify for a clinical trial are enrolled in the study at a local hospital, research center or clinic.
• Study administrators, on-site doctors or principal investigators provide study-related care for each patient during the course of the study.
• During the study, some participants may receive investigational drugs, while others may receive a placebo, and others may receive prescribed drugs. Placebos are substances that do not have any medical effects (usually a sugar pill). Study administrators use drug(s) versus placebo measurement in their study data collection.

Joining a Clinical Trial

Not every clinical trial is a “fit” for every patient. All clinical trials have eligibility criteria—a set of rules that doctors and researchers are required to follow as they determine who can participate in a trial. Typical eligibility criteria includes:

There is also likely to be additional criteria that is specific to your condition. This would include the type and stage of your breast cancer, other treatment methods that you’ve tried, and how long it has been since you were last treated.

Deciding to Join a Clinical Trial

Before deciding to participate in any clinical trial, you should carefully weigh the potential benefits against the risks.

Potential Benefits:

• Participants who choose to enroll in a clinical trial help others by contributing to the advancement of medical care.
• Those that enroll in a clinical trial may receive access to investigational drugs.
• If a drug proves to be effective in a clinical trial, some patients may benefit from the effect of investigational drugs or procedures.
• The trial sponsor may reimburse some or all of the costs associated with your medical care and transportation to/from study locations.

Risks:

• Unanticipated side effects may occur. These side effects may be worse than those associated with standard/traditional treatments.
• Because many clinical trials use placebos (typically a sugar pill) on a portion of the study population, there is no guarantee that you’ll receive the new treatment.
• New treatments do not always turn out to be an improvement over standard treatments.
• As with any standard drug or procedure, clinical trial treatments may not be effective for you even if they work for other patients.