A clinical trial is a carefully controlled study that attempts to answer a specific medical question, using human volunteers. In this article, “clinical trials” refers to research into the effects of experimental drugs or procedures designed to treat stage 4 breast cancer. These may include new drugs or new combinations of drugs, new approaches to surgery, or experimental radiation therapies. Other types of clinical trials are used to research preventive care, screening and diagnostic options, and ways to improve quality of life for people with chronic medical conditions.
Are clinical trials safe?
Clinical trials are generally regarded as safe. They must meet stringent guidelines through internal review boards within the research facility. Trials must also pass a strict review from the FDA. Patients who participate in clinical trials must be informed of the purpose of the study and any known risks, side effects, or long-term effects. Patients also have the right to drop out of the trial at any time, for any reason. If any harmful effects become known during the study, the researchers are required to remove patients from the trial.
Phases of clinical trials
Clinical trials are separated into phases according to how new and/or untested the treatments are:
- Phase I clinical trials are essentially safety studies. These studies determine how safe a treatment is in various doses and in treating different types of cancers.
- Phase II clinical trials look at the treatment’s effectiveness for a particular type of cancer.
- Phase III clinical trials expand on the phase II trials. They study the effectiveness of the treatment compared to the current standard of care. They also look at how its effectiveness varies in combination with other drugs, or according to dosage and timing of doses.
- Phase IV clinical trials are conducted after a new treatment gains approval from the FDA. These study the long-term effects and effectiveness of a treatment. They might also answer new questions that may have been raised about the treatment.
How can clinical trials help?
Clinical trials allow patients an opportunity to take part in the latest, cutting-edge treatments. These trials expand the total number of options available to patients. They also offer opportunities to try potentially effective new treatments. Placebos are generally not used in breast cancer clinical trials. Patients would be informed if placebos were used in a study they were considering. Trials usually compare the new treatment with the current standard of care. This means that patients who don’t get to try the experimental treatment still receive the most effective known treatment.
Patients are helping more than themselves when they participate in clinical trials. Each new treatment evaluated under clinical trials helps pave the way for saving more lives in the future.
How can you take part?
You doctor may recommend clinical trials designed for your type of cancer. The hospital or treatment center where you receive care may offer clinical trials in-house. The American Cancer Society offers a free Clinical Trials Matching Service. This service matches individual patients with open clinical trials appropriate for their situation.
There are also well-known research and medical centers that post their clinical trials online. Some of the best places to look include:
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medicine
- National Cancer Center at the National Institutes of Health
- MD Anderson Cancer Center
- Moffitt Cancer Center
- Mayo Clinic