Dispelling Misunderstandings About Clinical Trials

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As a clinical trials specialist for The Leukemia & Lymphoma Society, I guide blood cancer patients and their families through the process of determining whether a clinical trial might be right for them. I try to clarify any misconceptions people have about what is involved so they will be in a much better place to make a decision. This blog addresses some of the most common misunderstandings.

Considering a clinical trial for treatment of a blood cancer? Make sure you know the facts.

I Might Get a Placebo

A placebo is a substance that looks the same as the one used in the clinical trial but has no active ingredients. Most people think of a placebo as a ‘sugar pill.’ Placebos are almost never used in cancer clinical trials. In the rare instance a trial involves a placebo, you will be told before you agree to participate.

Patients enrolling in Phase I or Phase II trials all receive the experimental treatment. In Phase 3 trials, doctors are trying to learn if the experimental treatment is better than the proven or ‘standard of care’ treatment. In order to find out, half the participants will be given the standard of care treatment and the other half will be given the experimental treatment. The combined results of one group are then compared to the results of the other. Neither participants nor their doctors can choose which treatment they will receive.

There is one situation where a person with cancer might receive a placebo. Sometimes doctors want to understand if adding another drug to the standard of care treatment will improve the outcome. In this case, half the patients would receive the standard of care treatment plus the experimental drug; the other half would receive the standard of care and a placebo.

If there is any chance you could possibly receive a placebo, it is reassuring to know that federal regulations require you to be told of that possibility before you agree to enter the trial. It is also reassuring to know that trials, including those where placebos are used, are monitored carefully and can be stopped if one group is doing significantly better than the other.

All Costs Will Be Covered by the Company Conducting the Trial

This is a complicated issue and one that you should discuss in detail with the research physician or trial coordinator before you agree to participate in a trial. In very rare instances, all costs are covered by the sponsor of the trial, but in most cases, your insurance carrier will need to pick up a share of the expense.

Think of the costs involved as falling into two buckets: 1) Costs related to the research and 2) costs related to ongoing patient care.

The study drug, administration of the drug, and lab and imaging tests required for research purposes only are covered by the trial sponsor. Costs that would have been incurred had you not taken part in the trial (those related to your ongoing cancer care) need to be covered by your insurance carrier. That includes expenses such as your regular office visits and lab and imaging tests.

Occasionally, the trial sponsor will pay for some of your travel or other costs associated with increased visits, such as child care. This is often addressed on a case by case basis and is always worth asking about.

The National Institutes of Health Clinical Center in Bethesda in Maryland is one of the only trial sites in the U.S. where medical care is provided to children and adults participating in clinical trials without charge. The following information is found on the NIH website:

There is no charge for medical care received at the NIH Clinical Center. Participants will be responsible for costs for travel to their initial screening visits. Once a participant is enrolled in a trial, NCI will pay for transportation for subsequent trial-related visits for participants who do not live in the local area. In addition, these participants will receive a small per diem for food and lodging expenses if they are being treated as outpatients. However, it is important for participants to maintain current health insurance for medical care that is required outside of the trial or that is provided away from the Clinical Center.

Children and young adults up to the age of 22 can be treated at St. Jude’s Children’s Hospital in Memphis, TN for no charge. If an uninsured child is accepted for admission into a clinical trial, St. Jude will cover all treatment costs. If the child has insurance, St. Jude will cover all treatment costs not covered by insurance.

Clinical Trials are for People with No Other Options

Clinical trials are available for patients at all stages of disease, from the newly diagnosed to those who have exhausted all other treatment options.

Patients whose disease has progressed despite available treatments frequently look to clinical trials as an additional treatment option. But there are many trials open to patients with early stage disease.

For example, patients with multiple myeloma who have early-stage disease and no symptoms are most often monitored as opposed to being given treatment. This approach is called watchful waiting or active surveillance. Despite much evidence to support this treatment strategy, some patients want to pursue a more active treatment approach. One option for some of these patients is a clinical trial testing a cancer vaccine for those at risk of developing symptoms in 18 months to two years.

Go to LLS's clinical trials page to learn more about whether a trial is an option for you, what participating involves, and how to find one. Contact our Information Resource Center at (800) 955-4572 and be referred to our clinical trial specialist.

Click here to read “Is a Clinical Trial Right for You?”


Margaret (Peg) McCormick, RN, BSN, is a nurse psychotherapist who previously worked in patient advocacy relations in the pharmaceutical industry. She is a clinical trial specialist for the IRC and loves digging deeply into the science and supporting families, even in the most difficult of circumstances.

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