4 Questions You Should Ask Before Participating in a Clinical Trial
Cancer care has evolved drastically over the last few decades. Depending on the type and stage of your cancer, your care team may offer treatment options that might include radiation therapy, chemotherapy, or surgery. For example, patients with early-stage breast cancer may undergo surgery and/or radiation therapy.
Outside of these commonly recommended therapies, clinical trials may provide hope in the form of new and exciting treatments. Memorial Sloan Kettering Cancer Center, a top-ranked provider of oncology services, defines clinical trials as “research studies that test new treatments to see how well they work."1
According to the University of Virginia School of Medicine, clinical trials may be appealing to certain cancer patients because “…[patients] have exhausted standard (approved) treatment options—which either did not work for them, or they were unable to tolerate certain side effects. Clinical trials may provide another option when standard therapy has failed.”2
Patients considering a clinical trial should start by talking to their oncologist. The following 4 questions provide a starting point to help patients understand how the clinical trial works, whether they might be eligible, and what the potential risks and outcomes are.
Question 1: Am I eligible for this clinical trial?
Before considering a nonstandard treatment, you and your doctor must thoroughly go over a clinical trial’s “protocol,” which the National Institutes of Health (NIH) defines as the background, methodology, and approach of the treatment; who can participate, how long the treatment will last, and what tools are used (for example, medicine, radiation, surgery); and expected outcomes (for example, benefits, risks, side effects).3
Question 2: What are the benefits and risks of participating in a clinical trial?
According to the NIH, “The goal of clinical trials is to determine if these treatment, prevention, and behavior approaches are safe and effective.”3 So it’s important to know as much as possible about how the course of treatment will affect your health. For some patients, a clinical trial may represent the chance to extend life after standard treatments have run their course. For other patients, clinical trials may offer an exciting breakthrough not possible with standard treatments.
However, potential side effects and adverse reactions to new treatments can be difficult to predict, as clinical trials do not have long histories of patient data. ClinicalTrials.gov notes that "Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention)".4
Your doctor should be able to explain what you may expect out of a clinical trial and provide a summary of all the known or suspected risks.
Question 3: How long does the treatment take, and how intensive is it?
These questions are defined within a clinical trial’s protocol (see Question 1). It is critical for you and your doctor to pay special attention to the duration of the treatment, or how long it will take from start to finish, as well as how much it might affect your overall health. Likewise, if the trial uses innovative but potent treatment tools—for example, powerful new medicines, intensive radiation, or innovative surgical techniques—you and your doctor will want to weigh benefits against risks.
Question 4: How is this treatment paid for?
Because many clinical trials are on the cutting edge of medicine, their eligibility for health insurance coverage can vary. According to the National Cancer Institute, many health plans are required to cover the routine costs of a clinical trial.5 Other costs, such as extra testing, are not covered by insurance but are generally covered by the institution conducting the clinical trial.
One important exception to consider is that states do not have to cover routine clinical trial costs through Medicaid. Please check with your plan administrator (for example, a private insurance company, Medicare, or Medicaid) to determine in advance what will be covered.
Making the decision
Depending on your specific circumstances, clinical trials could be an effective part of your treatment plan. As always, it's best to discuss trials with your doctor so he or she can help steer you in the right direction. For additional resources, visit:
To search for clinical trials, visit the NIH's clinical trial locator.
What is a clinical trial? Memorial Sloan Kettering Cancer Center. https://www.mskcc.org/cancer-care/clinical-trials/what-clinical-trial. Accessed February 22, 2018.
Questions you should ask. University of Virginia School of Medicine. https://research.med.virginia.edu/clinicalresearch/participate-in-a-trial/questions-to-ask/#squelch-taas-accordion-shortcode-content-4. Accessed February 22, 2018.
NIH clinical research trials and you. National Institutes of Health. https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics. Accessed February 22, 2018.
Learn about clinical studies. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/about-studies/learn. Accessed June 5, 2018.
Insurance coverage and clinical trials. National Cancer Institute. https://www.cancer.gov/about-cancer/treatment/clinical-trials/paying/insurance. Accessed February 22, 2018.
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