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As
a volunteer in an Emory-centered study of polycystic ovary syndrome
(PCOS), I’ve been helping researchers study the effects of
two drugs on this condition, which affects an estimated 5% to 10%
of women.
While I’m not affected by all
of PCOS’s symptoms—which range from the hallmark multiple,
enlarged ovarian cysts to high insulin levels and acne—my
hormones must have betrayed me when I went in for a prescreening
in December.
A week later, Tammy Loucks, the director
of clinical research projects for Emory’s Department of Gynecology
and Obstetrics, called to tell me I qualified for the study.
When I got her call, I didn’t
know if I should feel like I’d won a prize (only 5% of women!)
or been handed a giant, billowing red flag. Knowing I have PCOS
means I’m at greater risk of developing diabetes, being overweight,
and becoming infertile.
Emory’s study, says Loucks is
targeting two of the major signs of PCOS—excess androgens
and insulin resistance. Until now, no one has studied how manipulating
these PCOS symptoms affects ovulation.
Researchers will compare the effects
of rosiglitazone (a drug that lowers insulin levels) and flutamide
(a drug that lessens the impact of androgens) with a placebo. Both
drugs have been approved by the Food and Drug Administration, but
not for PCOS.
A month after agreeing to participate,
as I lay in that Emory hospital bed and watched nurses use their
fingers as divining rods, gently searching for a plump, rich vein
in my arm, I finally figured out that maybe, just maybe, the prize
was the red flag. |
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Where
it all happens |
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The
study of PCOS is just one of an estimated 150 clinical trials
currently active in Emory’s NIH-funded General Clinical
Research Center (GCRC). The others include studies of Parkinson’s
disease, Mediterranean diets, and early diabetes detection and
prevention. Still in the planning stages are studies that will
look at chronic fatigue syndrome and a new therapeutic agent for
HIV-positive patients.
Based at Emory University Hospital,
the GCRC is auspiciously located across from the hospital’s
bakery (or, as I like to call it, the General Cookie Resource
Center), just a few steps away from the folding tables that appear
occasionally in the hallway as various vendors offer blood screenings
and spangled bracelets. Grady Memorial Hospital is home to another
Emory-run GCRC, which works in tandem with the center at Emory
Hospital.
“The goal of the GCRC is high-impact
translational clinical research,” says transplant surgeon
Tom Pearson, who serves as interim director. “A successful
GCRC will have a diverse portfolio of clinical research activities.
“Emory has a strong long-term
track record, and the challenge is to try and build on that,”
says Pearson. “As an academic health care center, I think
one of our unique and really important niches is taking information
from the bench and having an impact on human health.”
To casual observers (me, to be specific),
Emory meets the challenge: In 2004, volunteers accounted for a
total of 1,180 overnight stays at the GCRC. GCRC nursing director
Joyce Oglesby estimates that the GCRC had more than 2,000 outpatient
visits in 2005.
Including the research at the GCRC,
there are more than 600 clinical trials of new drugs, devices,
and procedures under way across the Woodruff Health Sciences Center,
says Missy Douglas, associate director for clinical trial affairs
at Emory School of Medicine.
These include research in both inpatient
and outpatient settings and studies examining new treatments for
common conditions as well as life-threatening diseases.
Through participation in a clinical
trial, many Emory patients not only have access to the latest
treatments but also the chance to learn more about their disease
or condition and to interact with clinical investigators leading
research in that area, Douglas says. |
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Why
volunteers sign up |
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Researchers
and volunteers often share
the belief that research is, as GCRC nurse Janice McMahan says,
“fascinating.” But while researchers tend to be interested
in scientific inquiry for its own sake, volunteers’ fascination
often begins as curiosity deeply rooted in personal experience.
As McMahan says, “Some [volunteers]
just want the personal information they get from lab results or
physical exams. Some want to help humanity.”
In my case, my doctor warned me as a teenager that my erratic menstrual
cycle might be due to PCOS. Seven years later, when I first responded
to the call for volunteers, I was simply tired of being in the dark
about my own body.
Besides considering the personal information
I’d receive and the, ahem, contribution to humanity I would
make, it also didn’t hurt that I feel comfortable at Emory.
My mom worked in the hospital when I was a teenager and had signed
me up to be a candy striper, or junior volunteer, for a few summers.
Two years ago when a bleeding ulcer in my father’s stomach
threatened his life, it was Emory’s emergency doctors who
diagnosed and stabilized him. Emory’s GI specialists repaired
the damage to his stomach and gave him blood transfusions. And Emory
nurses and staff wiped his forehead, brought him meals, and administered
pain medication. Might participating in this study be a small way
of saying thanks? Absolutely. |
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Like
religion, but not |
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Over
the past few months, I’ve found that if you want to feel like
part of something larger than yourself, you can find religion, or
you can volunteer for a research study at Emory.
I showed up out of curiosity. I stay
because I now know that my body, specifically my blood (all 72 vials
and counting), is helping unravel a puzzle much more awesome than
the sum of its—or my—parts. As Loucks says, “We
wouldn’t be able to do the kinds of work that needs to be
done without volunteers.”
It’s because we volunteers feel involved with something larger
than ourselves—something with consequences far beyond our
own bodies’ idiosyncrasies—that we submit our veins
to cold needles and relinquish our medical histories. It’s
why some of us collect our own stool, urine, and saliva samples—sometimes
for weeks—and write down every bite we eat. It’s why
we fast overnight, consume certain foods and abandon others, stay
overnight in a hospital, and submit to more needles. It’s
why, for three months, I am swallowing down large green capsules
twice a day that contain rosiglitazone, flutamide, or a placebo,
identified for now only by the containers in which they come: Bottles
A and Bottles B.
In the midst of this great experiment,
it seems to me that volunteering, in its essence, is the act of
intentionally making yourself vulnerable, of submitting to a series
of metaphorical trust falls, each time from a ladder a little higher
up, each time falling back with the faith that the many arms of
Emory will be there to catch you with the same purposeful tenderness
with which they pierce your skin and draw your blood.
So for two more months now, I will
swallow down pills A and B each morning and each night. Then I will
lie back down again in an Emory hospital bed, look up at Emory nurses,
and offer up my arms, my blood, my hormones, my day off, my red
flag, and my prize. It’s amazing how quickly 12 hours and
72 vials pass by, when you’re in the middle of something big. |
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Getting
the Word Out |
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Though
it’s often the researchers and pharmaceutical
companies who garner the headlines, each new blockbuster drug
hitting the market owes its existence to legions of anonymous
volunteers who participated in years of research studies.
On average, each new drug requires
the participation of 4,000 volunteers as it passes through
the three main stages of research.
But as the number of potential new drugs rises, the number
of volunteers willing to help is declining, experts say, leading
to significant delays in getting new therapies from the lab
to market.
According to the Center for
Information and Study on Clinical Research Participation,
approximately 80% of clinical trials nationwide are delayed
by at least a month because investigators are unable to recruit
enough participants.
Surprisingly, research indicates
that many people are willing to serve as study subjects but
don’t know how to participate. A recent Harris Interactive
poll found that 70% of respondents indicated they would be
willing to take part in a clinical trial, but many said they
had little to no information about what volunteering for a
trial would involve or how to access information about trials
in their area.
The WHSC Clinical Trials Improvement
Project hopes to address these issues by raising awareness
about the clinical trials under way here.
“It is so critical that
we get this information out to our faculty and staff as well
as the larger community about this unmet need,” says
Missy Douglas, associate director for clinical trial affairs
at the Emory University School of Medicine. “Currently
in the United States, low participation in trials extends
the amount of time that it takes to get drugs and devices
to market and ultimately increases cost. But more important,
it postpones the benefit of new treatment options.”
Few trials involve as many blood
draws or procedures as the one Dana participated in, says
Douglas. And many do not involve the use of placebos. Some
trials offer participants with a particular illness or disorder
the chance to try promising new therapies before they become
commercially available.
Some of the trials that are
still open for enrollment can be found on a special Emory
Healthcare website or by searching the national
clinical trials database using a keyword search for “Emory.”
Patients can also call Emory HealthConnection at (404) 778-7777
and talk with a nurse about clinical trial options available
at Emory.
Emory researchers who would
like more information about posting trial information online
should contact the Clinical Trials Office at (404) 778-4960
or visit the website online (click
here). |
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