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FROM TEST TUBE TO MEDICINE
CABINET: HOW FDA APPROVED DRUGS ARE DEVELOPED
By Cheryl D. Munson, Creative
Solutions, Writer/Producer
ATLANTA, GA - Turn on your
television or flip through a magazine, and you’ll see a message
about a new medication to cure just about anything that ails you.
Yet most of us have very little knowledge about the journey a drug
takes to make it out of a test tube and into our medicine cabinet.
The answer to how many drugs
make it to market actually lies a lot closer than you may think. A
great number of the drugs and pharmaceuticals that we have come to
depend on to improve and even extend our lives are available to us,
thanks to clinical trial research performed at the Atlanta Research
Center.
Based in Northeast Atlanta near
the DeKalb Medical Center, The Atlanta Research Center is one of the
most sought-after and highly recognized research facilities in the
United States. The center focuses on investigational drug therapies
for common chronic diseases affecting women, including osteoporosis
and arthritis.
Since the Atlanta Research
Center began in 1991, over 500 residents in metropolitan Atlanta
have participated in its research studies. By doing so, Atlantans
have directly contributed to the availability of widely prescribed
drugs such as Merck’s Fosamax® and Vioxx®, Pfizer’s Femhrt®,
Celebrex®, and Bextra®, Novartis’ Miacalcin®, Lilly’s Evista®, and
Proctor and Gamble’s Actonel®,
Dr. Grattan Woodson, a third
generation Atlanta physician, heads the Atlanta Research Center. He
completed his undergraduate studies at Oglethorpe University,
received his medical degree from the Medical College of Georgia, and
is currently a Clinical Instructor of Medicine at Emory University.
Dr. Woodson’s hospital affiliation is with DeKalb Medical Center.
CLINICAL TRIAL RESEARCH – THE “COMING OUT
PARTY” FOR NEW PHARMACEUTICALS
While thousands of potential new
drugs are tested in the United States each year, only a handful pass
the extremely rigorous testing for safety and effectiveness enforced
by the US Food and Drug Administration (FDA).
The process that gets a new drug
out of the test tube and into your medicine cabinet is called the
clinical research trial. “Through the clinical research trial
process, we test drugs to make sure they are both safe and effective
for the treatment or prevention of a specific medical condition like
osteoporosis,” says Dr. Woodson.
Clinical trial testing is an
extremely comprehensive, three-phase process which can typically
span anywhere from 5 to 7 years. In the first phase, drugs are
tested in a small number of volunteers to determine their safety.
In Phase II, drugs are tested to determine which dosage is best.
Many drugs are entirely
abandoned because they do not pass the safety requirements of
the pharmaceutical company or
the FDA during Phase I or Phase II studies.
PHASE THREE – THE FINAL TESTING FRONTIER
“Phase III is the final testing
frontier, when the drug is tested for both safety and effectiveness
in a larger number of patients” says Dr. Woodson. This is when
involvement by the Atlanta Research Center shifts into high gear.
Phase III testing is the specialty of the Atlanta Research Center.
Volunteers for Phase III testing
are sought through a variety of efforts, including announcements on
television, radio and in print. “Our clinical research team begins
by screening potential volunteers who call us by conducting a
general health questionnaire over the telephone.
The interview usually takes
between 15 and 20 minutes. 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 in a study. 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
patient really has a good idea of what the risks and benefits are of
participating in a study. It is our job at the Atlanta Research
Center to explain the study in the fullest possible terms to our
patients before any study procedure is performed. We take this
responsibility very seriously and often spend an hour or more going
over every aspect of the study with the patient” says Paula
Thompson, LPN, and one of the Clinical Research Coordinators at the
ARC.
Next, volunteer participants 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, participants
are randomly placed into one of several trial groups, and receive a
preset dosage of the medication or a placebo. 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, an Assistant
Clinical Research Coordinator at the ARC.
Based upon the study,
participants receive services that can include physical exams,
gynecological tests and examinations, mammograms, many laboratory
assessments, along with continuous close overall monitoring of the
participant’s health.
RESEARCH VOLUNTEERS CONTRIBUTE TO THE HEALTH
OF GENERATIONS NOW – AND GENERATIONS NEXT
Recruiting volunteers to
participate in research poses ongoing challenges. The sponsoring
pharmaceutical companies, understandably, have extremely stringent
criteria for who can and cannot participate in clinical trials.
Achieving the required number of participants for a study can take
anywhere from 3 to 12 months.
Another recruitment challenge is
getting a volunteer participant “population” that reflects racial
diversity in order to determine whether there are any adverse risks,
and higher or lower effectiveness traits specific to racial
make-up. Unfortunately, the center reports that recruiting African
Americans for clinical trial studies has been specifically
difficult.
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 common thread for volunteering is a desire to
further medical advancements and improve the quality of life for all
mankind.
Woodson says, “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. |
