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.