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Clinical trials are research studies in which people volunteer to try new therapies and treatments (under careful supervision) in order to help doctors identify the best treatment plans with the fewest side effects. These studies help improve the overall standard of care (the treatment regimen that most physicians and experts widely agree is the most effective and appropriate for a specific subtype and stage of cancer). Clinical trials are an important step in discovering new treatments for cancer and other diseases as well as new ways to detect, diagnose, and reduce the risk of disease. On average, a new medicine to treat a cancer has been studied for at least 6 years (and sometimes many more) before a clinical trial on it is started. Clinical trials show researchers what does and doesn’t work in people. Clinical trials also help researchers and doctors decide if the side effects of a new treatment are acceptable when weighed against the benefits offered by the new treatment. Because clinical trials are required for FDA approval, every medication–even Tylenol, Benadryl, Aspirin, Tums, etc.--has gone through a clinical trial. In addition to exploring new medications, clinical trials also increase our understanding of all the factors that can influence cancer diagnosis and survival: diet, exercise, environmental factors, genetics, stress, and many more.
Black Patients carry a heavy cancer burden, and the research must reflect that. Black people are underrepresented in clinical cancer trials relative to our disease burden. Fixing that clinical trial participation gap starts with getting the right patients in the right trials. With low participation rates in clinical trials, Black people miss access to newly emerging and often life-extending treatments not otherwise available. But more than that, clinical trials are used to answer major questions: Does the new treatment or procedure work? Is what's being tested better than what's being used now? Does it cause more or fewer side effects?
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Research is designed to protect patients. The National Research Act was signed into law in 1974, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. As a result, all clinical trials require participants to give informed consent. During the process of informed consent, the clinical trial research team must clearly explain how the trial will work, the trial’s purpose, and its risks and benefits. Only then can you agree to enroll in the trial. The purpose of the informed consent process is to help protect participants and make sure they have a full understanding of the trial and their rights before they decide to enroll. Standard of care is the treatment regimen that most physicians and experts widely agree is the most effective and appropriate for a specific subtype and stage of breast cancer. During a clinical trial, you will always receive standard of care and/or the new drug. If at any point during the trial, the new drug isn’t working effectively for you, they will change your treatment to standard of care. Because the doctors and researchers are invested in finding the best treatment for patients, they pay incredibly close attention to everything that is happening to a trial participant. Clinical trial participants receive closer attention as well as more frequent scans and testing throughout their treatment.
You can consider a clinical trial any time you are making a cancer treatment decision. The truth is, there are opportunities for people with all stages and types of cancer—from those newly diagnosed to those in treatment to those in remission—to participate in clinical trials. Clinical trials are not a last resort. In fact, many clinical trials focus on early-stage breast cancer. Know your options! Clinical trials can look at all different things, from drug-based treatments to the impact of stress to sleep patterns. While most people think of chemotherapy and other drugs when they think of clinical trials, clinical trials actually investigate quality of life and lifestyle, too.
Yes! Clinical trials are voluntary and you can choose to leave for any reason, at any time.
Clinical trials shouldn’t cost you anything–there are many trials that take on all of the expenses of their participants.
Clinical trials should be a treatment option at every stage of cancer, not just a last resort. Ask your doctor about clinical trials early and often. “Everybody should be asking,” advises Dr. Sara Horton, breast oncologist at Howard University Hospital. “If you’re unfortunate enough to get a cancer diagnosis, you need to ask your oncologist about clinical trials because unfortunately, not all of them are going to present the option. Not every practice has access to clinical trials and not everyone needs a clinical trial, but I always say ask. Do you think I’m appropriate for a clinical trial?”
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