Clinical Trials

Understanding Clinical Trials

Clinical trials are conducted when a drug or therapy is thought to be of value to the patient or for treatment of the disease. Clinical trials are separated into different phases depending on how much is already known about the drug or therapy. A treatment regimen must be studied in all three phases before it can be approved by the FDA (Food and Drug Administration).

Phase I: The goal in a phase I study is to find the best way to administer a new treatment and to determine the amount of drug that can be given safely.

Phase II: In phase II studies the goal is to see if the treatment works; the highest, safe dose has already been determined by the phase I study.

Phase III: In phase III studies the treatment is administered to a large number of people. Usually, a control group receives the standard of care therapy and the study arm (which may or may not be blind) receives the proposed new treatment. The purpose of having a control arm is to be able to compare the new treatment to the current standard therapy.

Participating in a clinical trial may be beneficial to you and/or it may help people with melanoma in the future. It is important to remember that as a patient, you always have the right to decline participation in a clinical trial at any point, even if you’ve already begun the study treatment. The links below are excellent resources to find clinical trials that you or someone you know with melanoma, may be eligible to participate in.

Resource: National Comprehensive Cancer Network

http://www.nccn.org/

http://www.cancer.gov/clinicaltrials

http://www.cancertrialshelp.org/

http://www.clinicaltrials.gov/

http://ecog.dfci.harvard.edu/

http://www.swog.org/

http://www.calgb.org/