Clinical trials are research studies in which patients volunteer to help find answers to specific research questions that are typically for new treatments. Over the last decade, the majority of clinical trials in prostate cancer have been in the advanced prostate cancer setting. These clinical trials have resulted in many new, effective treatment options for men with this condition. For men who are dealing with a prostate cancer diagnosis and treatment, thinking about joining a clinical trial may be overwhelming and unsettling. This article will debunk seven myths about participating in a clinical trial.
Myth #1: “Once I join a clinical trial, I can’t change my mind”
As part of joining a clinical trial, a patient must sign paperwork called “informed consent.” This paperwork lets the research team know the patient is willing to enroll in a trial and understands the risks and benefits of the trial. However, patients are free to leave a clinical trial at any time for any reason (even after signing informed consent). They will not be in any way punished, and they will receive the best available care from their doctors.
Myth #2: “If I join a clinical trial, I’ll be treated as an experiment or a guinea pig”
The majority of clinical trial participants report that they feel fully informed of the risks and benefits of the trial, as well as being treated with the utmost respect and dignity. In fact, many participants feel like they receive extra attention and have more people observing them during the clinical trial. This also includes a study nurse who helps guide their treatment and follow-up. Although a clinical trial cannot guarantee better outcomes for every patient, safety is a top priority in all clinical trials and patients have rights that protect them. As well as informed consent, each research institution participating in a clinical trial has an independent committee called an Institutional Review Board (IRB). The IRB reviews and monitors clinical trials to ensure they are being performed ethically. Additionally, each trial has a data safety monitoring committee. The data safety committee continually reviews the information of all individuals participating in the trial to ensure that there are no unforeseen risks.
Myth #3: “Clinical trials are dangerous because they are giving patients untested drugs/medications”
Because clinical trials are designed to answer important questions, all research does have some level of risk. However, whether or not a drug or treatment has been tested already in humans depends on the phase of the clinical trial.
- Phase I trials are the first time a study is tested in humans, aiming to enroll 10-100 patients. At this stage, researchers are testing a treatment for safety. This phase lasts from a few months to a year.
- Phase II trials enroll patients to test for both safety and effectiveness based on the goals of the trial. Phase II trials can last from several months to a few years and typically aim to enroll 200 patients.
- Phase III trials are usually large trials that enroll hundreds or thousands of patients. At this stage, patients are put into either the control group (the standard of care—the best available treatment) or the test group (the treatment under investigation). Patients do not know which group they are placed in, which is known as “randomization.” These trials provide the investigators and the FDA with data on the treatment’s effectiveness and side effects. As part of the informed consent process for any trial, safety information is fully disclosed. Individuals also have the opportunity to ask questions.
Myth #4: “If I join a clinical trial, I may get the placebo or ‘sugar pill’”
In prostate cancer trials, a placebo is only used if there are no existing treatments available, which means the clinical trial is comparing a new medication to a placebo. In reality, prostate cancer trials rarely use placebos because the best available treatment, called the “standard of care,” is used as the “control group” for the trial.
Myth #5: “Clinical trials are more expensive for the patient”
Routine medical costs include patient care costs, tests, or procedures that patients would typically have received whether they were or were not participating in the clinical trial. These costs are most often covered by a patient’s insurance plan. Research costs are associated with taking part in the trial. These costs are covered by the trial sponsor. If you have any concerns about which costs are covered, be sure to discuss this with the clinical trial team.
Myth #6: “Participation in prostate cancer clinical trials is not important”
Every treatment available to men who have prostate cancer was approved through a clinical trial. Because of this, clinical trials are very important. Clinical trials give researchers and doctors insight into better ways to treat prostate cancer. They also help others, including future generations of men who are diagnosed with prostate cancer. Although the clinical trial process may take years and may not directly benefit you, you may feel like you are “paying it forward.”
Myth #7: “Clinical trials are for men that have run out of other treatment options”
Clinical trials are always an option for all patients, regardless of when they have been diagnosed with prostate cancer or what previous treatments they have received. Although new treatments may be tested in clinical trials among men who have had several types of treatment and have limited remaining options, there are many trials in all stages of prostate cancer.
The advancement of prostate cancer has relied on clinical trial participation for decades. Indeed, new treatment options cannot be approved by the FDA until they have been tested carefully in clinical trials. For men who are interested, this means there is no better time to enroll in a clinical trial than now.