When a patient is diagnosed with cancer, there are many questions, fears, and concerns that need to be addressed. Among these considerations is whether to participate in a clinical trial if one is available and the patient is determined to be eligible. This is a highly personal decision that only the patient can make, but it’s an option well worth exploring in coordination with an oncologist.
According to Pam Shoup, CCRP, Toledo Clinic Oncology Research Manager/IRB Coordinator, cancer clinical trials are vital not just to the current patient population, but also to the future of cancer care. “Clinical trials allow access to new drugs and other cancer treatments. Through trials, new drugs are tested against the current standard-of-care treatment to determine whether they’re beneficial and safe. Unless patients are willing to go on clinical trials, we can’t answer these important questions,” she says.
Cancer patients are encouraged to discuss the option of enrolling in a clinical trial with their oncologist, who will be able to determine whether the patient’s particular diagnosis meets the eligibility requirements for the trial and will work closely with the clinical research coordinators and the healthcare medical team to answer any questions the patient may have about the trial as well as assist in their participation. Shoup notes that the Toledo Clinic Cancer Centers oncologists are very knowledgeable in this regard and have over 30 years of experience participating in clinical trials through the National Cancer Institute.
Among the barriers to cancer patients participating in clinical trials is the fear that they’ll receive a placebo instead of an active treatment, they’ll have to sacrifice regular treatment and interaction with their physician, or they’ll be treated like a “guinea pig.” But as Shoup explains, these perceptions are based on myth.
“Placebos may be used in cancer clinical trials, but never if it denies the patient a more effective therapy or puts them at greater risk of harm. For example, many clinical trials are testing the standard-of-care treatment plus the investigative drug or the standard-of-care treatment with a placebo. So, at the very least, the patient is receiving the current standard of care. Also, many times clinical trials have several ‘arms’ to the study that may allow for a patient’s treatment to cross over from a placebo to the investigative drug if it is determined his or her disease has progressed,” she says.
It’s also vital for clinical trial candidates to be aware that they won’t have to sacrifice anything with respect to regular treatment if they choose to participate. In fact, to assess whether there is any potential benefit to a new drug or treatment, regular care must be ongoing throughout the study, taking into account factors such as the type of cancer, the current stage of the disease, and all the patient’s known medical and health conditions.
Shoup further comments, “At a minimum, not only is standard treatment completed, but many times clinical trials require extra testing, such as additional lab values and scanning procedures that are routinely covered by the study. Patients are asked to interact very closely with their oncologist, clinical research coordinators, and medical team to monitor any adverse events, potential risks, and benefits the patient may be experiencing from the treatment, and to document whether the patient is experiencing any response to the new drug or treatment or progression of the disease.”
Perhaps the biggest myth related to clinical trials is that once enrolled, participants are essentially “guinea pigs” who sign away their rights and have no control over what’s done to them. But the reality is, clinical trials have many protections and safeguards built into the clinical research process.
The most important of these safeguards is an institutional review board, or IRB, consisting of both scientific and non-scientific members, whose responsibility is to review and approve—or disapprove—a clinical trial before it’s used in a particular clinical setting as well as to ensure that the trial follows approved ethical guidelines to protect patients and the integrity of the science.
Once the IRB has approved a clinical trial for use at the facility and the clinical trial has been deemed an appropriate treatment approach for the patient, the oncologist and clinical research coordinators will carefully review an informed consent document with each willing participant. The informed consent document outlines the purpose of the study, the benefits one may receive, the risk that could be associated with participation, any additional testing or procedures that will be required, any costs the patient may incur, individuals and organizations that will be allowed to review the data obtained, how confidentiality of the patients medical information is maintained, and who the patient should contact with any questions regarding their treatment, rights, or ongoing participation in the study.
“Informed consent is more than a document that requires a signature by the patient and the clinician. Rather, it is a process to ensure each patient has a clear understanding of what the clinical trial is about and what the expectations may be for their participation in the study. Most importantly, patients always have the opportunity to withdraw from the clinical trial if they wish to,” Shoup states.
Entering a clinical trial does not guarantee that a patient will have increased benefit from the treatment compared to a patient being treated outside of the clinical trial. What is known is that the treatment they receive will be, at the very least, as good as the treatment they would receive off study. Shoup explains, “Patients participating in a clinical trial are not only choosing an option they feel is best for them, but they may also find comfort knowing they are contributing to the advancement of medical science and cancer research—and possibly paving the way for better treatments for future cancer patients.”❦