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.

An IRB’s main responsibility is to protect the public from harm and look
carefully at each study’s methods to make sure the research is done in an
ethical way.

Does drug effectiveness vary across
races?

There are many therapies to which African Americans
are known to respond differently than whites.1, 2 For example, some drugs are
less effective in African Americans (such as beta blockers for hypertension),
some cause increased adverse events (such as occurrence of angioedema with use
of ACE inhibitors), and some show both types of differences. 1, 2

One study 3 showed that although ACE inhibitors are particularly effective in
whites, but not African Americans. A combination of hydralazine plus isosorbide
dinitrate reduced the mortality of black patients. At the same time, white
patients given this combination of drugs showed no difference from placebo
(sugar pill). The study concluded that clinical trials involving large numbers
of black patients are needed to further clarify their response to therapy.

Another study compared enalapril therapy for heart failure among blacks and
whites.4 Enalapril therapy reduced the risk of hospitalization for heart failure
among white patients with left ventricular dysfunction, but not among similar
black patients. Again, the researchers concluded that their findings underscored
the need for additional research on the efficacy of therapies for heart failure
in black patients.

How can I participate in a clinical
trial?

Not all studies involve drugs; some long-term studies
will only ask you to have a physical and fill out some paper work every few
years. Other studies need “controls”-people who don’t receive the treatment so
the results of those receiving treatment can be compared with them. You have the
right to quit any study you become involved in at any time.

What questions should I ask before
participating in a clinical trial?

If you want to become
part of a clinical trial, ask questions about the risks and benefits of the
study.

  • What is the study about?
  • Who put this study together?
  • How/when will I learn the results?
  • Who is going to be in this study?
  • What will I get out of this study?
  • How will I be protected from harm?
  • How will my privacy be protected?
  • What will I have to do?
  • What will I leave behind through my participation?