Five Common Myths About Clinical Trials

Better cancer treatments depend on clinical trials of new drugs and other therapies, but in the United States, only 3 percent of cancer patients participate in these investigations of new therapies.

clinical trialsPatients often hesitate to participate because they don’t understand the process or have misconceptions about what it means for them.

“There’s a national lack of understanding of why we do clinical research and where it takes us,” says Michele Russell-Einhorn, JD, Senior Director of the Office for Human Research Studies at Dana-Farber Cancer Institute, Dana-Farber/Harvard Cancer Center. “We could all do a better job of educating people about clinical trials.”

Russell-Einhorn clarified some myths and misunderstandings that can sometimes keep potential trial volunteers from joining a clinical trial:

 

Myth: I will get a placebo instead of an experimental treatment.

Fact:  Placebos are rarely given in cancer clinical trials. The great majority of studies compare the standard treatment with a new, investigational drug or treatment.  If there was any possibility you might receive a placebo, that would be made very clear in the informed consent process.

 

Myth: I will have to stop my standard therapy to participate in a clinical trial.

 Fact: Many clinical trials include standard therapy as part of the study, which may be testing an additional drug to see if the combination is more effective. In some other studies, the patient remains on standard therapy but provides other information for a study through questionnaires or having material from the tumor analyzed and stored in a tumor registry.

 

Myth:  If I am found ineligible for a clinical trial, I won’t be able to participate in any other trials.

Fact: Every trial has its own eligibility criteria. For example, a study of an investigational drug may require that the patient cannot have had previous treatment for the cancer. But that doesn’t necessarily disqualify the person from some other kind of trial.

 

Myth: I won’t have access to an experimental drug when the trial ends, even if it is working.

Fact: This varies from one trial to another, and is spelled out in the informed consent. However, Russell-Einhorn says research centers’ institutional review boards (IRBs) normally urge the drug company sponsoring the trial to continue to make the drug available if it is benefiting the patient.

 

Myth: I will have to pay out of pocket for treatment received in a clinical trial because insurance won’t cover experimental therapy.

Fact: Many state and federal laws require insurance companies to cover the cost of participation in  a “qualifying cancer research intervention protocol.” Individuals who participate in research may still have to pay the deductibles associated with their standard of care treatment.  Experimental drugs are frequently provided free by the sponsoring manufacturer. Health insurance typically covers charges related to tests and treatments carried out during a clinical trial that would be done anyway for standard treatment. Prospective research subjects are advised in the informed consent document about the costs of participation in the research.

Answers to many questions can be found in the online booklet, Entering a Clinical Trial – Is It Right for You?  

2 responses to “Five Common Myths About Clinical Trials

  1. My mom has been talking about participating in some clinical trials. I thought that most trial like this would give out placebos, so I am glad to know that that is isn’t always the case. Thanks for clearing up some of the myths people have come up with. Maybe it would be a good idea for her to get involved in some new trials.

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