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:
- Why don’t more African Americans participate in
clinical trials?
- How can a person be sure that a clinical trial
is safe?
- Does drug effectiveness vary across
races?
- How can I participate in a clinical
trial?
- 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.
Clinical Trial Diversity: The Need and the Challenge was originally published on blackdoctor.org
