On Point — One Opinion, what's yours?

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.

Where it all happens

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.

Why volunteers sign up

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.

Like religion, but not

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.


	Getting the Word Out

	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).