URGENT NEED FOR MORE AFRICAN AMERICANS TO
PARTICIPATE IN CLINICAL TRIAL RESEARCH STUDIES
By Cheryl D. Munson, Creative
Solutions, Writer/Producer
THE ATLANTA RESEARCH CENTER STRIVES TO CHANGE ATTITUDES,
ELIMINATE FEARS, AND INCREASE VOLUNTEER DIVERSITY.
ATLANTA, GA - While African
Americans are a minority of the population in the United States,
they are even more of a minority when it comes to having access and
taking advantage of the gold standard for developing innovative new
pharmaceuticals used in medical treatment: clinical trial research
studies. It is estimated that less than 3% of clinical trial
participants in the United States are African American.
“The problem is even more
magnified right here at home in Atlanta. While African Americans
represent over 60% of the greater metropolitan Atlanta population –
they still mirror the national statistic, and only make up 3% of
participants in clinical trials,” says Dr. Grattan Woodson, Medical
Director of the Atlanta Research Center.
“Researchers, drug companies,
and the FDA have simply not, until recently, recognized that this
was even a problem. In my opinion, this was not intentional
discrimination, but appears to have occurred due to simple
insensitivity and bias. After all, it was, for the most part, white
men who decided what diseases were going to be studied and which
people were going to be study participants,” says Woodson.
The ARC specializes in Phase III
clinical trial studies for osteoporosis, menopause management, and
Hormone Replacement Therapy. They have been on the leading edge of
Phase III clinical trial studies which have resulted in bringing
drugs to market such as Merck’s Fosamax® and Vioxx®, Pfizer’s
Celebrex® and Bextra®, Lilly’s Evista® and many others.
A Phase III clinical trial is
the largest endeavor in medical clinical research. If, and only if a
drug passes Phase III testing can pharmaceutical companies request
FDA approval so that the drug can be used or prescribed for general
use.
“The truth of the matter is that
almost every new drug that has ever been introduced has been
thoroughly tested in only one racial sub-type: white Americans.
This is so despite the fact that drugs are intended for use by all
Americans. We have found that some drugs have different effects in
non-white patients. Unless every new drug is tested in every racial
group expected to use it, we can never say for sure whether a
difference may be important or not. Right now we’re conducting
studies on several highly promising new medications for HRT (Hormone
Replacement Therapy) which show great promise on reducing the risk
for developing breast cancer, a leading cause of death among African
American women. That’s why it is important that more African
Americans volunteer. We could be on the verge of finding
significant information that could benefit the health of African
Americans here at home – nationwide – and worldwide,” Woodson
states.
FEAR FACTORS. WHY ARE AFRICAN AMERICANS
RELUCTANT TO VOLUNTEER?
Medical professionals,
researchers and the pharmaceutical industry often site fear,
deficient access to adequate healthcare, lack of insurance, and a
historic mistrust of the healthcare industry as primary reasons why
African American participation in clinical trial research is neither
proportionate to their percentage of the population, nor at a rate
comparable to research volunteers in general.
Much of the mistrust stems from
a notorious scar: the infamous Tuskegee Study, conducted in Macon
County, Alabama when nearly 400 African American men with syphilis
were observed for four decades, but not given treatment.
Interestingly enough, many
healthcare professionals today will actually site the Tuskegee Study
as an instrument that generated beneficial change in the clinical
trial research for everyone, not just African Americans. Rigorous
new standards for testing, full disclosure of study benefits, risks
and informed consent of patients are mandatory and strictly enforced
requirements.
Yet even despite the
improvements, regulations and changes there still remains a general
lack of awareness among African Americans of the advantages and
benefits of participating in clinical research studies.
“There is also an overall
misunderstanding of the entire clinical trial process. There’s a
mystique about it. Surprisingly, many people, and not just African
Americans, think that drugs go straight from the test tube to
testing on humans. But there are three, highly screened, extremely
monitored phases involved. In Phase One, drugs are tested in
laboratory settings. In Phase Two, they are tested in highly
controlled hospital settings. It is only when a drug passes Phase
One and Phase Two that they get to the third, and final drug testing
frontier: Phase Three clinical trials, the specialty of the Atlanta
Research Center. Only a small fraction of all drugs even make it to
Phase III clinical trial testing,” Woodson describes.
BENEFITS OF VOLUNTEERING
There are real, tangible
benefits to volunteering as well as noble, intangible rewards.
While all clinical trial research facilities are prohibited by their
pharmaceutical affiliates or government sponsors from promoting the
financial aspects of volunteering, it is standard to provide a small
stipend for each office visit a study participant is required to
attend.
Beyond that, there are the very
important benefits of free medical services, which at the ARC often
include pap smears, mammograms, comprehensive physical examinations,
biopsies and blood tests. These services can sometimes become
out-of-pocket expenses unless they are medically required by a
primary care physician, specialist, or necessary due to an existing
condition. However as a research volunteer they are often mandatory
requirements under the guidelines of the sponsoring pharmaceutical
company or government agency in order to continually track and
monitor the participants’ health status.
AFRICAN AMERICAN WOMEN IN ATLANTA WHO DARE TO
BE EXCEPTIONS TO THE RULE.
Just as there are a host of
reasons why African Americans don’t participate – African Americans
who do choose to volunteer speak strongly about their decision to
become exceptions to the rule.
“I’m a nurse. So I know that
most research studies don’t include us. I wanted to make sure I did
my part to change that,” says Alice Gunn, of Stone Mountain. The 49
year-old mother of three is a study volunteer at the ARC for an HRT
alternative medication. “I hope that the data collected through my
participation opens up the door for even more studies and research
that will benefit African Americans. In these studies you can find
out if you’re having problems that you might not have known about
otherwise.”
Alma, a 57 year old from
Clarkston honestly states the health care benefits as a reason why
she became a volunteer. “I don’t have health insurance. So this
became a way that I could at the very least find out what’s going on
with me, medically.”
Phoebe Jackson Mitchell, a 51
year-old self-employed cosmetologist in Riverdale gives reasons for
volunteering that span from personal to posterity. “I’m getting
health care services that my insurance probably wouldn’t cover, and
that I don’t have the money to do myself, like bone density testing
and getting a complete, total physical. You couldn’t ask for
anything better than that.” She’s quick to add her nobler reasons,
“I also wanted to help our people and do something for society. I
have a daughter and a granddaughter. So I believe that what I’m
doing is going to be beneficial for them as well.”
THE VOLUNTEER EXPERIENCE
“Our clinical research team begins by screening
potential volunteers and conducting a general health questionnaire
over the telephone. When we find a volunteer with the qualifications
required for a study, we invite them to come to the Atlanta Research
Center for a formal screening visit,” Woodson describes.
The visit begins with a thorough discussion of the
full spectrum of risks and benefits of participating in the research
study. This disclosure is also given to the volunteer in a formal
written document which the volunteer signs to verify their
permission to participate. This very important process is called
obtaining “Informed Consent.”
“The FDA has built-in numerous safeguards into the
Informed Consent process to insure that the volunteer really has a
good idea of the risks and benefits. We take this responsibility
very seriously,” says Paula Thompson, LPN, and one of the Clinical
Research Coordinators at the ARC.
Next, volunteers are tested. If test results fall
within guidelines set by the sponsoring pharmaceutical company, the
volunteer can enter the active portion of the clinical trial. At
this point, they are randomly placed into one of several trial
groups, and receive a preset dosage of the medication or a placebo
(meaning a non-drug or “sugar pill”). No one knows, not even the
Atlanta Research Center staff members, whether a participant is
receiving actual medication or a placebo.
The length of time that a participant will be
involved in the clinical trial can typically range from 3 months to
5 years. During this time period, the participating volunteers
receive extensive medical testing.
“Once the study is underway, carefully monitoring
the patient to make sure they stay safe is our most important task,”
points out Julie Underwood, a Clinical Research Coordinator.
HOW TO DECIDE IF VOLUNTEERING IS RIGHT FOR YOU
The reasons why people elect to
volunteer for clinical trial studies are many and varied.
Some volunteers suffer from the
very illness or disease for which the potential drug is being
tested. Some have, or had a mother who suffered from osteoporosis.
Or a close friend whose lifespan was shortened, resulting from a
fracture or fall.
The Atlanta Research Center
advises all people, no matter what race, to ask some very important
questions before making the decision to become a clinical trial
research volunteer:
Why is the study being done?
What is the goal and objective
for the study?
Who is eligible?
What results do they expect to
achieve?
What are the known risks and
side effects of the drugs being studied?
How and when can a volunteer
elect to withdraw from the study?
Volunteering can be a long-term
commitment. The final reason-why should never solely rest on the
need for free healthcare, but rather on exploring whether the
benefits outweigh any potential risks, and having a strong desire to
further medical advancements and improve the quality of life for all
humankind.
Woodson adds, “I view
volunteering for medical clinical trial research studies as the
ultimate selfless act. It enables you to truly be instrumental, and
directly contribute to improving, extending and saving lives for
generations now – and generations next.”
For more information about
current and future clinical trial research studies and to receive
information about becoming a volunteer, contact: The Atlanta
Research Center, 2801 North Decatur Road, Suite 375, Decatur, GA;
(404) 292-6300
THE ATLANTA RESEARCH CENTER is
one of the most sought-after and highly recognized clinical trial
research facilities in the United States. The center focuses on
investigational drug therapies for common chronic diseases affecting
adults, with an emphasis on new drugs for the prevention and
treatment of osteoporosis, arthritis, menopause and cardiovascular
diseases. |
