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?
Clinical Trial Diversity: The Need and the Challenge was originally published on blackdoctor.org
