September 23, 2016
By Dr. Rachel Raab, Director Mission Breast Program

For many cancer patients, the idea of participating in a clinical trial brings hope. They see it as an opportunity to receive a treatment that may be better than the standard of care, to advance science, and to help future cancer patients. For many patients, however, the thought of participating in a clinical trial is frightening. I often hear patients say that they do not want to be a “guinea pig” and fear receiving treatment that is “experimental.”

For an individual with cancer, it can be difficult to know if a clinical trial is the right treatment option. It is a myth that clinical trials are only for people who have advanced cancer that is not responding to treatment. Here is some basic information about clinical trials.

What are clinical trials?

Clinical trials are research studies that involve people and help doctors to find ways to improve treatments and the quality of life for cancer patients. Some clinical trials are done to treat cancer, some for prevention of cancer, others to find ways to manage symptoms of cancer and side effects from cancer treatments.

By the time a clinical trial reaches a patient in the clinic, it has gone through steps in order to ensure that the drugs being used are safe and effective. Scientists, or researchers, work in a lab for many years to understand how drugs affect cancer cells before these drugs are ever used to treat people.

Every clinical trial has a person in charge. This is usually a doctor who is called the principal investigator. Research nurses and other individuals are also involved in the trial to ensure that the trial is being run appropriately.

If a clinical trial is discussed with you or your loved one, this conversation should include information on why the trial is being done, who can join the trial, what drugs are being used, how often treatment is given, what side effects can occur, what medical tests will be done and how often, the type of information that will collected from the trial and what this information will be used for.

What are the phases of clinical trials?

Phase I clinical trials are used to show that people can safely use a new drug or treatment. In phase I clinical trials, the dose of the drug being studied is slowly increased with the goal of finding the dose that works best without causing severe side effects. People who join phase I clinical trials are often the first to get a new therapy or combination of therapies.

Phase II clinical trials give information about a treatment’s safety and how well it works. Before a treatment can move into the next phase of a clinical trial, the phase II clinical trial needs to show that the treatment is as safe as standard treatment.

Phase III clinical trials compare the new treatment that has shown to be effective in a phase II trial with the standard of care for that particular type of cancer. Patients are randomized to one of the treatments. These trials include a large number of patients and take years to finish.

Why are clinical trials important?

Clinical trials help doctors find new and better cancer treatments that can help patients live longer. They help doctors better understand side effects from treatment and how to prevent and manage them. They help improve quality of life for cancer patients. People are living longer, better lives because of clinical trials.

(From Mission Health Blog; Mission Health has served Western NC since 1885)