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Clinical Trials or Standard of Care: A Common Dilemma or Cancer Misconception? Debunking Myths about Cancer Clinical Trials

Clinical trials are a major step in improving the standard of care for future cancer treatment. They also offer patients of today access to potentially life-extending innovative therapy. Countless cancer patients have benefited from the novel treatment given via clinical trials. However, only 2-3% of cancer patients participate in trials due to siloed information, physician attitudes, and competition between cancer centers. Moreover, patient perspectives may be influenced by misconceptions surrounding a typical participant’s experience. Let’s debunk these common myths about clinical trials.

1. I will be treated like a guinea pig.

Before researchers conduct clinical trials with human participants, years of reviews and tests take place. Pre-clinical studies use cancer cells grown in a lab and cancers in live animals to ensure that the treatment is safe for humans. The US Food and Drug Administration (FDA) must give permission before any treatment can be tested with people. By this point, researchers have a better understanding of the drug to inform prospective participants of the risks and benefits beforehand. Phase 0 trials are the first clinical trials done among people. These are rare and are typically considered ‘pilot’ studies. Phase I trials usually look into the best dosage amount for the tested drug, but that doesn’t mean there is no data behind them. When researchers look for a specific cancer type or other factor like a mutation, there is often a very good reason to believe they can be successful. Now that therapies are being created more specifically for certain types of cancer, phase I trials often test the most advanced medicines with some of the greatest potential for benefit. Moreover, phase II trials assess the safety and efficacy of the treatment with a specific type of cancer. Phase III trials compare novel treatment to the standard of care. In Phase IV trials, drugs approved by the FDA are tested in hundreds or thousands of patients. As trials progress into different phases, the researchers become more accustomed to the expectations of the tested drug. However, it is difficult to choose a trial based on phase alone, which is why we help patients and their physicians understand the pros and cons to each. Overall, most patients who have participated in a clinical trial report having a positive experience. 

2. There is a chance I get a placebo so that I won’t receive any treatment at all.

In science experiments, a placebo (a sugar pill or something that has no effect on what is being studied) is used as the control group. However, in cancer clinical trials, the development of new treatments examines if the standard of care can be improved. Thus, the control group typically receives the standard cancer treatment. Everyone in the study will receive some care, whether that is the standard treatment or novel therapy. Any treatment you may receive in a clinical trial will be outlined before you agree to enroll. Look out for clinical trials labeled blinded or not blinded. When a patient is randomly assigned treatment in a not blinded trial, that patient will be informed of the exact treatment they will receive.

3. I will have to pay to participate.

Typically, the sponsor of the clinical trial covers any costs associated with the research and treatment. Additionally, costs considered “routine care,” which are tests that patients already have to take, such as blood tests, and radiology tests, are covered by insurance. Make sure to confirm with your insurance provider that they will take care of those costs before enrollment. Expenses that fall on to the patient are nonmedical costs, such as transportation and childcare.

4. Once I enroll in a clinical trial, I am committed to it.

Patients often appreciate that clinical trials allow them to be under close observation of a medical professional throughout the process. Thus, if the patient’s cancer progresses, the principal investigator typically removes that patient from the trial. Also, if the treatment provokes intolerable side effects, that patient can safely choose to leave. Concluding participation in a clinical trial is easier than most people expect; patients are able to leave any time. In some cases, patients choose to leave as soon as they learn that they will not receive the novel treatment.

5. Standard care and innovative treatment are mutually exclusive.

Many people assume that treatment options are separated into the categories of the standard of care and novel therapies. Whereas in reality, there are many situations where innovative treatment and standard of care work together. For example, some clinical trials test innovative treatment that often includes a mix of a standard drug and a new drug. Patients also find themselves in situations where they need the standard of care treatment to reach a stable condition for clinical trial enrollment. Another approach is switching between the two treatments. We often recommend patients seek innovative therapies in between cycles of standard of care to maximize the potential for remission. Ultimately, we believe that to achieve the best outcome, patients should personalize their plan after looking into both standard of care and clinical trials.

6. Enrolling in a clinical trial is for last resorts.

Clinical trials offer the opportunity to receive treatment that is more effective than the standard of care, which can be helpful for cancer patients at any part of their journey. The goal for nearly all oncology trials is to “do better!” Doing better usually involves improving efficacy or acting just as good if not better than the acceptable treatment. There are clinical trials for all stages of cancer, some designed for a specific stage. Trials often aim to help patients who have late stage or advanced cancers to live longer, and help those with early staged cancers to lessen the chances of it coming back (i.e. increasing the cure rate). Additionally, there are cancer clinical trials that pay attention to the side effects, symptoms, or quality of life induced by a treatment. Some clinical trials also test the advantage of using new medical technology. Thus, it is best to get the help of an expert who has experience with reviewing clinical trials so you can focus on the ones that are best for you.

Clinical trials are a viable and useful treatment option for cancer patients. When weighing the risks and benefits of enrollment, consult real experiences and professional medical knowledge. Myths that arise from misinformed information could prevent a patient from receiving the treatment they need. Whether a patient is battling a poor prognosis, exploring the best treatment options, or looking to further medical science, we recommend clinical trials to any cancer patient who could benefit from innovative treatment. 

While it is critical to decide on the right next steps, it is equally important for many patients to know that additional options are available if the current ones are too harsh or ineffective. This knowledge instills patients with hope along their cancer journey.

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