Patients who are eligible to participate in a clinical trial always have a lot of questions before they sign on. Here are a few of the most commonly asked questions about clinical trials and how they work:
IS THIS SAFE, OR AM I GOING TO BE A GUINEA PIG?
Clinical trials must meet strict guidelines established by organizations like the U.S. Food and Drug Administration and the National Cancer Institute. Keck Medicine of USC also has an Institutional Review Board (IRB), which ensures that trials are safe and ethical. Doctors, nurses and other key staff members keep close tabs on clinical trial participants to ensure their safety. The IRB can stop a study if it appears to be causing unexpected harm or the risks outweigh the benefits. It can also stop a study early if the new treatment is clearly effective and should be offered to more patients who could benefit from it.
I AM NOT SURE I UNDERSTAND THIS WELL ENOUGH TO AGREE TO IT.
Everyone considering participating in a clinical trial will receive information about the study, including their rights and how the study will be conducted. Called “informed consent,” this process ensures that staff members address any concerns a patient might have before signing up. Patients are encouraged to ask questions and discuss the trial with their own health care team as well as the study investigators to weigh possible benefits and risks.
WILL I EXPERIENCE BAD SIDE EFFECTS?
Every drug, even approved drugs, has potential side effects. But the Keck Medicine medical team closely monitors side effects and helps patients manage them. I’m worried I’ll get a placebo and won’t get the best treatment. Placebos are not used in every clinical trial. Usually, patients either receive the standard treatment, the drug under investigation or both. Placebos are used when testing a treatment for a disease for which there is no effective therapy.
WHAT IS THIS GOING TO COST?
Participating in a clinical trial doesn’t cost more than what patients already pay for health care. Visits that must be done as part of the research will not cost the patient anything.
WHAT ARE THE BENEFITS OF PARTICIPATING IN A CLINICAL TRIAL?
Clinical trials can provide aggressive options for patients who need it or early access to treatments that are not yet available. Patients may also benefit from the additional interactions with Keck Medicine’s medical professionals. In addition, volunteers have the satisfaction of knowing that they helped advance science and treatment for other patients.
CAN I STOP PARTICIPATING ONCE I JOIN A TRIAL?
Yes, participation is voluntary and participants can stop at any time.
AREN’T MOST CLINICAL TRIALS TO TEST NEW DRUGS FOR SERIOUS ILLNESSES?
Not every clinical trial evaluates a new drug for people with serious illnesses. Some trials test old drugs for new uses while others try to prove that a new device improves on an older one.
Here are three clinical trials at Keck Medicine of USC that shed light on how academic medicine can evolve the practice of health care:
Breast Cancer Detection
USC Norris Comprehensive Cancer Center is testing SoftVue, a new way to find breast cancer early. Among women with dense breast tissue, mammograms sometimes fail to spot small breast tumors. But the new SoftVue technology looks at the breast with ultrasound, rather than the X-rays involved in mammography. SoftVue exams take a picture of the entire breast using sound waves and water. The technology images the breast in a single pass without radiation or compression and can differentiate tissue qualities to better identify possible cancers. In this trial, participants have both a mammogram and a SoftVue exam to compare the two techniques. Learn more at the SoftVue site.
Memory Protection Through Nicotine?
Smoking is by no means recommended for people with dementia, but nicotine, when it is delivered by transdermal patch, might slow down the progression of memory loss. Nicotine is known to activate certain receptors in the brain associated with memory function. Now Keck Medicine researchers are testing whether nicotine can slow the progression from mild cognitive impairment to Alzheimer’s disease. In this research study, participants with mild cognitive impairment (signs include confusion and poor judgment) are given increasing doses of nicotine for two years. Researchers monitor patients’ memory and other cognitive functions during the study. Learn more about what’s called the MIND trial.
Sleep Apnea Testing
Before Surgery One option for sleep apnea is surgery, but that doesn’t always fix the problem. Surgery focuses on removing part of the soft palate, the primary region of the throat responsible for sleep apnea. In other people, though, snoring comes from the area of the tongue. Keck Medicine researchers are evaluating whether a test called drug-induced sleep endoscopy can refine treatment strategy before patients head to surgery. In this procedure, patients are sedated, and when they start snoring, doctors insert a flexible scope into the nose to find the exact source of the blockages. Physicians hope the evaluation will improve outcomes for sleep apnea patients undergoing their first surgery, as well as those who have undergone unsuccessful operations. Learn more at Keck Medicine of USC’s clinical trials site.