Clinical Trial Diversity: The Need and the Challenge

    man in warehouse

    Clinical trials (also called medical research and research studies) are used
    to determine whether new drugs/treatments are both safe and effective. In
    addition, they help researchers decide if a drug’s risks are worth its benefits
    (risk/benefit ratio). The Food and Drug Administration (FDA) considers the
    results from clinical trials in approving a drug or treatment. Once approved,
    the therapy becomes available for doctors to prescribe to their patients.

    New therapies are tested on people in clinical trials only after laboratory
    and animal studies show promising results. It is a challenge for researchers to
    recruit adequate numbers of clinical trial participants, and even more of a
    challenge to recruit African Americans. This is a concern because there is
    evidence that certain drugs have different effects on African Americans than
    they do on Caucasians.  This article addresses the following questions:

    1. Why don’t more African Americans participate in
      clinical trials?
    2. How can a person be sure that a clinical trial
      is safe?
    3. Does drug effectiveness vary across
      races?
    4. How can I participate in a clinical
      trial?
    5. What questions should I ask before participating
      in a clinical trial?

    Why don’t more African Americans participate in
    clinical trials?

    There is a general distrust of the
    medical/healthcare system amongst some African Americans, and perhaps many,
    based on personal experience. In addition, historical events have given African
    Americans reason to mistrust clinical trials.

    On July 26, 1972, the New York Times reported on what it called the “longest
    running non-therapeutic experiment on human beings in medical history.”
    Departing from their Hippocratic oath to “first, do no harm,” physicians from
    the U.S. Public Health Service allowed nearly 400 poor, black sharecroppers with
    syphilis to go untreated for forty years. These men from Macon County, Alabama
    were told they were being treated for “bad blood.” However, they were all
    actually part of the Tuskegee Experiment, which was designed to study the
    progression of syphilis-a potentially fatal sexually transmitted disease.

    Many health professionals and leaders in the black community cite the
    Tuskegee Experiment as a factor contributing to low participation of African
    Americans in routine preventive care, clinical trials, and organ donation.
    However, we can be thankful that the Tuskegee Experiment did lead to a change
    for the better in how medical research is done.

    How can a person be sure that a clinical
    trial is safe?

    An Institutional Review Board (IRB) must
    approve all studies involving human or animal subjects in advance. Complaints
    should be addressed to the director of the study or the institution’s IRB.

    Institutional Review Boards (IRB) are made up of physicians, ethicists,
    religious leaders and other community leaders, and are required to look at
    studies which are going to use human or animal subjects.

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