The Clinical Guinea Pig

Being a medical trial volunteer pays off in dividends.

By Dena Levitz, Photos by Jonny Meyer

 

During the summer of 2001 Irwin Binder went out on the town and took his wife folk dancing. A spry 61-year-old who currently walks to work daily, Binder found it odd that the physical exertion tired him out so much that it caused him to perspire and lose his breath. But after sitting out a few numbers, he promenaded on.

It wasn’t until a few months later that the Germantown, Md. resident discovered that his ailment had been much more serious than a momentary ill feeling. He’d suffered a heart attack that night on the dance floor.

The unexpected diagnosis came when Binder showed up for an appointment to be a healthy volunteer in a research study at the National Institutes of Health (NIH). A routine MRI to set the framework for the study revealed blockage to 70 percent of his heart, and physicians were able to see visible evidence that a heart attack had, indeed, occurred.

As a direct result of that appointment, there were two major outcomes for Binder, a chemist and longtime government contractor: He underwent an angiogram to repair his previously unrealized heart condition. He also became hooked on volunteering for clinical trials.

“The experience made me feel very mortal and vulnerable,” he says of the heart attack. “But one of the positive things that comes out of the studies is I learn about myself.”

Unlike traditional doctor appointments, where Binder feels rushed through check-ups, he says researchers running trials tend to take great care and time to examine their subjects and researchers get to the bottom of the patient’s medical history, as the authenticity of their work depends on such accuracy. He’ll always finish up an appointment asking the physician on hand what they’ve learned about him that day, pushing the staff to give him new insight about his health and well-being.

“While I’m there I’m the only patient there, and [the researchers] are very good about providing information that can help in the long run,” he says.

In the past decade, Binder has been the control in an array of studies from one time testing out a new colonoscopy method to a year-long examination of a pending hepatitis vaccine. He doesn’t have a precise count on the number of clinical trials in which he’s played a role, but Binder has become, to NIH, one of their go-to volunteers.

In a region with a host of medical institutions testing out treatments, Binder is part of a sizeable—and sometimes misunderstood—class of residents who are regulars in the clinical trial circuit. They often work regular jobs and, in their free time, lend themselves to science as guinea pigs for modest compensation.

By all accounts, NIH is the longest running and largest recruiter of healthy volunteers, having utilized them since 1954. According to the institute’s Office of Communications, almost 56,000 healthy volunteers have registered for studies from August 1995—when a tracking system was implemented—through March 2011. At press time, NIH had 392 study protocols on file in which healthy volunteers were participating in some sort of fashion.

The volunteers run the gamut in terms of age and occupation, as do the studies to which they subject themselves. Studies can require a single visit or span over the course of multiple years. And, subsequently, researchers can ask for physically taxing tasks like blood draws, rounds of immunizations or regimens of prescription pills or simply require volunteers to complete a questionnaire about their behavior or their mindset.

“The role of healthy volunteers varies greatly, depending on the study,” says Dinora Dominguez, chief of the Patient and Recruitment Section of NIH’s Communications Office. “Each participant must meet protocol-specific eligibility criteria.”

Regardless of the NIH department involved in running the study or the subject area in which their research falls, the value of healthy volunteers is crucial, “because their health information can be used as a comparison,” according to Dominguez.

“In some studies, researchers need to compare healthy volunteers with people who have a specific disease or condition. Research with healthy volunteers is designed to develop new knowledge,” Dominguez explains.

Besides NIH, healthy volunteers in the region flock to Walter Reed Army Institute of Research, which studies a selection of diseases and frequently tests products such as cutting-edge insect repellent. Since 1992, the facility has recruited upwards of 350 volunteers annually for its studies.

“Usually that involves the volunteer taking a medicine, receiving a vaccine, or using a medical device and then being carefully followed up with examinations and laboratory tests,” the institute states to potential volunteers via its website. “Sometimes, clinical trials involve using a product and then being challenged to see how effective the product actually is.”

One of the newer regional medical centers using healthy volunteers is the Clinical Alliance for Research and Education-Infectious Diseases (Care ID). Based in Annandale, the 6-year-old facility partners with pharmaceutical companies and government agencies to develop preventative care and treatments for infectious diseases.

The numerous higher education campuses in the region, including Georgetown
University as well as Johns Hopkins Medical Center, are among those that conduct studies and are popular institutions that healthy volunteers frequent.

Talking to those who submit to clinical trials, the inevitable first question is “Why?”

For Ann Schlegelmilch, a psychology resident in Falls Church, the initial decision to be a healthy volunteer was partially about earning extra cash (while in graduate school in Norfolk, Schlegemilch says she constantly came across fliers advertising paid vaccine studies), and also partially based in her interest in medical discoveries.

“I was living on loans and had no time for a part-time job. It just seemed like a really easy way to pick up a little extra money,” Schlegelmilch says. “I can also appreciate that you need people to participate in your research to advance things.”

Specifically, Schlegelmilch signed up for two double-blind flu vaccine trials, in which she didn’t know during the course of the study whether she was given the vaccine being tested or a placebo. Compared to a vaccine for something like H.I.V., she felt that her risks were minimal. Doctors had her keep track of any adverse reactions at the site of the vaccination and come in for check-ups to monitor her progress.

“I was very healthy at the time. I don’t know if it was a placebo effect from thinking I was being vaccinated, but I didn’t have to call them with any negative results once,” she says.

Shortly after, Schlegelmilch also got involved in what she calls a quick-hit study at Virginia Commonwealth University, requiring only a mouth swab to retrieve some of her DNA for comparative analysis. Another time she came in for a single visit and gave blood so the Red Cross could use it to test out new ways of storing blood the agency gets from donors.

All of these experiences were a non time-consuming way to make a contribution, which is why Schlegelmilch says she’d lend her services again if a suitable opportunity presented itself.

“I now work in medical facilities and have done research myself,” she notes. “I can see the benefits in general [of using volunteers for studies]. It’s how we make improvements in care.”

This interest in giving back has been a strong pull for Jill Aubry as well. The 67-year-old Arlington resident has been involved with clinical trials on and off for decades, mostly at smaller private institutions where it’s convenient for her to drive to the location.

Originally, Aubry was inspired to volunteer because of her father, who at age 75 started participating in studies as a means of aiding patients in a different way outside of his regular job.

“He was a pharmacist and operated a one-man pharmacy where I spent many formative years,” she says. “After he died, I continued to volunteer at Capital Hospice doing speaking presentations as well as investigational studies.”

Over time, Aubry has lent her body to exercise and sleep studies, visiting the participating research facilities in her spare time around various full-time jobs in the teaching field. For the past few years she’s primarily searched Craigslist to find individual studies, which she says is a common technique among other frequent healthy volunteers.

Aubry says she doesn’t need the money, so she likes to pool study payments together and then keep a stash for gifts and splurges for herself and her family. She can also afford to be selective about which research to pursue.

“I’ve gotten something from every study I’ve ever done,” she reports. “My common denominator is that I have to find it interesting and worthy.”

Given the experimental nature of clinical research, is taking part risky behavior?

It’s a consideration most healthy volunteers mull over when searching for and, ultimately, signing up for trials.

From the perspective of NIH, there are checks and balances in place to minimize dangers and ensure that the study is critical enough to complete, according to Dr. Christine Grady, deputy chief of the Bioethics Department at the Institute’s Clinical Center.

“One of the ethical requirements of all research involving people is that any risk be justified by the importance of doing the study and that the risks be minimized as much as possible,” she says. “The investigator writes a study proposal describing the reason for doing the study, including a description of the potential risks and benefits, and the steps taken to minimize any risks. An independent committee reviews the study to make sure that any risks associated with the study are acceptable and minimized.”

Healthy volunteers participating in the study must receive detailed paperwork from the lab outlining the risks and benefits. After learning about the study, each volunteer opts in or out.

Still, all the healthy volunteers interviewed described the pursuit as more of a solo endeavor than an accepted activity among loved ones. Aubry, for one, says that being a healthy volunteer is not incredibly difficult to do, yet she’s in the minority of those in her circle who will take part.

In addition to the safeguards implemented by the medical institutions, many volunteers, like Binder, develop informal rules that guide what they are and are not willing to do personally to assist researchers, as well as principles that they try to abide by while in the studies.

For instance, Binder takes great pains to not be in conflicting studies. NIH and some other institutions don’t encourage subjects to be in more than one trial at a time. Yet many healthy volunteers report that the process of being accepted into research studies is a bit like dating; waiting for that one Mr. Right might mean missing other suitors, so it can be advantageous to try out for several projects and then reevaluate involvement if accepted into multiple studies.

In terms of what’s performed, MRIs and other diagnostic devices don’t cause Binder any nervousness like they do for some. So he signs up for these types of examinations frequently. In the case of a study trying out a new colonoscopy technique, Binder was willing to put up with some discomfort because he viewed the test as crucial to men in his age group. NIH actually did not pay him for his role in that study, but being able to get a complimentary colonoscopy was payment enough, he says.

Those around Binder have, at times, expressed concern about his heavy involvement in clinical trials.

“But I think it’s very important,” he says. “I don’t do anything that will be a substantial risk … And I really am committed to getting good results for the researchers.”

 

Pros & Cons

As with everything a person partakes in, there are always benefits and risks involved. The U.S. National Institutes of Health breaks down the pros and cons associated with participating in clinical trials.

Benefits

Participants have the opportunity to become actively involved in their health care.

Participants have access to new treatments and medicines.

Participants work with expert medical staff to which they otherwise would not normally have access.

Participants are giving back to the overall medical community.

Risks

Due to the nature of any clinical trial, participants may experience unpleasant, serious or even life-threatening side effects.

The treatment may not have successful outcomes for all participants.

The time requirement for the overall process is more significant than traditional medical treatments.

Source: clinicaltrials.gov

 

(August 2011)