Clinical trials, research trials, and studies all refer to the process that investigates the effectiveness of a new drug, type of therapy, or combination of drugs. There are 3 main phases of an investigational treatment along the road to FDA approval. Phase I trials are small, and 100 percent of the patients receive the investigational treatment. The focus of these studies is to determine a safe and effective dose of the treatment. Phase II trials are a little larger and focus on determining a drug’s anticancer effectiveness. Phase III trials are very large. The goal is to confirm the safety and efficacy of the drug in comparison to the current “gold standard” of therapy. A survival benefit—making someone live longer—is the most common requirement for FDA approval.
If a patient is interested in a participating in a clinical trial, I recommend they start with the physician who is most familiar with their case. A second opinion from an expert is a logical next step. In addition, there are valuable websites i.e., www.clinicaltrials.gov that provide listings of available clinical trials. When embarking on a clinical trial, after an initial screening process, patients are assigned to a treatment. Typically, a clinical trial comparing two or more treatments will be randomized by a computer.
I think it is important for patients to realize that clinical trials should not be reserved only when all other treatments have failed. They should be viewed as an added tool in the bag of treatment options. Medical advances are occurring so quickly that new medicines may only be available in a clinical trial. Additionally, clinical trials may save money by providing access to expensive medications free of charge. Lastly, clinical trials advance medical science. Men who participate in clinical trials are pioneers. We all need to offer thanks to every cancer patient who has taken that major step of joining a clinical trial.
ABOUT THE AUTHOR
Luke Nordquist, MD, FACP is board certified in internal medicine and medical oncology. He completed his oncology fellowship at Memorial Sloan Kettering Cancer Center and his residency in internal medicine at the University of South Florida/H. Lee Moffitt Cancer Center. He also has a bachelor’s degree in pharmacy from Creighton University. He was selected by the American Society of Clinical Oncology (ASCO) to sit on the Government Relations Committee, representing the interests of cancer physicians and patients on Capitol Hill. This influential committee is made up of 19 oncologists who are current ASCO leaders and several previous ASCO presidents. He is an expert panel member for the development of National Prostate Cancer Treatment Guidelines and a selected CALGB member designing new research studies for prostate & urologic cancers across the nation.