Clinical trials are extremely important scientific studies to assess new medical treatments, including treatments for diseases like prostate cancer. This article explores the reasons why clinical trials are necessary, what exactly they are, and how men with prostate cancer might benefit from clinical trials working to advance new therapies.
Improved Prostate Cancer Survival Rates
According to the most recent survey conducted by the NIH’s National Cancer Institute,1 an estimated 2,795,592 men are living with prostate cancer in the United States alone. The number of new prostate cancer cases is 137.9 per 100,000 men per year, while the number of deaths is 21.4 per 100,000 per year. Survival rates for prostate cancer have also greatly increased over time, and the five-year survival rate is now 98.9% according to the NIH. That rate is largely due to newly approved treatments that were assessed via clinical trials.
The wide range of treatments for prostate cancer, which includes watchful waiting, drugs, hormonal therapy, chemotherapy, radiation therapy, and surgery, was in large part made possible through clinical studies. Every therapeutic used in the treatment of the disease must be rigorously tested in actual prostate cancer patients before being approved by the U.S. Food and Drug Administration (FDA), and demonstrate both safety and efficacy.
Continued Need for New Treatments
Despite successes in treatment, prostate cancer still results in fatalities. In 2015, an estimated 27,540 people died from prostate cancer.1 Clearly, although current treatments have notably reduced prostate cancer deaths and improved survival, better treatments are still greatly needed — and wanted. Clinical trials are a necessary and required mechanism for testing and approving new therapies, so that they can be available for those who need them. In fact, clinical trials are essential to advance prostate cancer research and treatment.
Clinical Trials for Prostate Cancer Explained
What exactly are clinical trials? Clinical trials are well-designed studies that collect information about new treatments for diseases and disorders. Most of the time this means medications, but clinical trials can also test other approaches, such as stem cell therapies, surgical techniques, tests for diagnosis, or medical devices. In particular, clinical trials focus on administering an experimental therapy in humans, as opposed to animals. Animal testing — or the testing on cells in a dish (in vitro) — is conducted first in the lab and is typically referred to as “pre-clinical research,” or research occurring before a clinical trial involving patients begins.
Clinical Trials Are Required for the Approval of New Treatments
What exactly makes a clinical trial so necessary? Can’t doctors just start using a medication based on a study showing it is effective? The answer to this is, of course, no. Clinical trials are necessary for medical treatments to be approved by government regulatory agencies, such as the U.S. Food and Drug Administration. Without carefully designed and performed clinical trials, doctors and other healthcare providers (such as nurse practitioners or physician’s assistants) cannot prescribe medications or recommend other medical treatments. These studies are needed to understand two important types of information: 1) that the treatment is effective (also called efficacious), i.e., that it really works, and 2) that the treatment is safe for use in humans.
Clinical Trials Advance Scientific Knowledge, Assure Efficacy & Safety
In addition to helping patients by making the best possible treatments available, clinical trials also advance the scientific understanding of a disease or disorder.
It is important to make sure that a new drug is more effective than existing treatments, actually works in a disease, and that it is safe. Decisions to give drugs or other medical treatments have to come from scientific data, not just the opinion of a healthcare provider, patient, or other individual. Clinical trials help to assure all of these things.
Despite successes in the treatment of prostate cancer, new treatments — and new studies — are still needed. Clinical trials are a necessary mechanism that can help advance research, and they are a legally required step for new treatments to advance and eventually to be approved for use by physicians and their patients.
Be sure to stay tuned to Prostate Cancer News Today’s exclusive, ongoing series of articles on clinical trials for prostate cancer. Our next article will explore how prostate cancer clinical trials work, and what you need to know about how they are managed and what they seek to accomplish.