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How we protect patients during clinical trials

March 28, 2018 | Susan M. O'Brien, MD
uci health physician susan m. o'brien
Dr. Susan O’Brien is one of the nation’s leading leukemia experts and medical director of the cancer center’s Sue and Ralph Stern Center for Cancer Clinical Trials and Research.

At any given time, more than 200 clinical trials are taking place at the UCI Health Chao Family Comprehensive Cancer Center to help bring innovative drugs and technologies to patients quickly.

Despite the many benefits of clinical trials, some myths about them and their safety persist.

Live Well spoke with Dr. Susan O’Brien, one of the nation’s leading leukemia experts and medical director of the cancer center’s Sue and Ralph Stern Center for Cancer Clinical Trials and Research, about the facts and myths about clinical trials.

How do clinical trials benefit patients?

Clinical trials may offer hope for patients with diseases that haven’t responded to treatments that are the current standard of care.

If an investigational treatment turns out to be effective, trial participants will have benefited from the therapy long before it’s available to patients everywhere.

Patients in clinical trials are also closely monitored by experts who specialize in their specific condition.

Don’t some participants get a placebo (sugar pill)?

This is a common misconception about clinical trials. Placebos are rarely used. Sometimes patients receive a different drug or a combination of drugs in addition to the standard of care.

Some clinical trials that are designed to assess the preventive value of drugs or vitamins may use placebos for a control group of participants.

Is it true that you can’t quit a clinical trial once you have signed on?

No. You are free to stop participating at any time and to return to treatment with the standard of care.

Does health insurance cover clinical trials?

Most insurance, including Medicare, pays for patients to receive the standard of care.

Costs for anything more required for the study, such as extra office visits, lab tests or scans, would be paid by the company of the drug or device being tested.

In drug tests, most of the drugs are free of cost to the patient. This is really important in the case of oral cancer drugs, which can cost about $10,000 a month — with a copay. I have heard of copays of $1,000 a month for the standard care.

What other protections for patients are in place?

There are a number of regulations in place to protect clinical trial participants, including:

  • Manufacturers of new drugs must file applications with the U.S. Food and Drug Administration detailing what’s in the drug and how it’s manufactured.
  • Before a drug can be used in a clinical trial, the FDA requires companies to test it in animals — not just in mice, but in other mammals — to understand a drug’s toxicity and how it is metabolized.
  • Before any clinical trial can begin, the design of it is required to be submitted to the FDA for review, revision and approval.
  • The FDA monitors all clinical trials in progress.

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