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    When the research subject is you

    When and how to enroll in a clinical trial

    Last updated: May 2011

    Although my mother warned me never to volunteer, I always raised my hand in class—and I have always been a sucker for a good clinical trial. As a medical student, I entered a study that examined the allergic potential of a blood substitute. You guessed it: hives and swelling over my body for two weeks. Undaunted, I joined a study that looked at the effect of a female hormone on the liver. My liver remained fine, but my breasts got so tender that I had to withdraw. And years later, in 1982, I entered Harvard's Physicians' Health Study and, with 22,070 other male doctors, began taking a nondescript white pill—aspirin or a look-alike—every other day to see whether it would prevent a first heart attack. The study was halted after almost five years because of an observed 44 percent drop in heart attacks in the men taking aspirin. At last, my luck had changed: I was in the aspirin group.

    Barriers to enrollment

    Not everyone shares my enthusiasm for volunteerism, and research investigators are finding it increasingly difficult to recruit people for clinical studies. Some people might be turned off by the possibility of getting a placebo; others might fear side effects or being used as a guinea pig. Even the terminology that describes a clinical trial can create unintended bias. For example, a recent study from the Hastings Center found that the words "medical" and "experiment" had a negative impact on potential volunteers; "research study" had a more positive connotation.

    Perhaps the simplest barrier to enrollment is that people don't know that clinical trials exist. That's too bad, since participation in that research is an ongoing need for the benefit of society. A lack of evidence from well-designed trials would result in poor and even inappropriate uses of drugs and procedures—and put us back in the dark ages of practicing medicine with hunches and intuition.

    You can find a searchable registry of federally and privately funded studies recruiting volunteers at www.clinicaltrials.gov, run by the National Institutes of Health. Make sure that any study for which you volunteer meets these criteria:

    • It's conducted by a reliable group, such as a university medical center.
    • You will be told of all risks, both known and potential.
    • You can withdraw at any time and for any reason.
    • You retain the right to sue for any adverse effects related to the trial.
    • You will be told of the trial results.
    • Your identity will be kept confidential.

    Talk with your doctor before you sign up. He or she might know something that you don't.

    Marvin Lipman, M.D.

    Chief Medical Adviser and Medical Editor

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