University Times

Pitt’s Research Participant Registry reached a landmark last month by enrolling its 10,000th individual in less than two years. Participants have the opportunity to learn about or take part in Pitt and UPMC health studies.

One of the first of its kind, the registry is a component of Pitt’s Clinical and Translational Science Institute (CTSI), which was established in 2006 with an $83.5 million five-year National Institutes of Health (NIH) grant. (See Nov. 6, 2008, University Times.)

Pitt’s CTSI is one of the first dozen established with NIH funding. Now there are 55 such institutes.

Having 10,000 registered participants thus far has translated into the registry’s staff receiving more than 1,500 requests about specific studies. More than 300 participants, after completing the registry office’s pre-screening process, have been referred to study coordinators, according to Laurel Yasko, CTSI administrative director of operations.

“The way it is set up, you agree to be contacted about potential research studies. If you are interested, then you contact us. This is very participant-driven,” Yasko said.

When a participant calls, registry office staff describe the subject requirements to the participant, and pre-screen the person for eligibility prior to referral to a research coordinator, who will do a more comprehensive screening.

“We have about 100 studies in the registry that are actively recruiting participants, and a quarter of those are looking for healthy volunteers,” she said. “Most of these studies are being conducted by researchers in the School of Medicine, but every school on campus is represented in the registry.”

Recruiting subjects for clinical research studies is an age-old hurdle for researchers, Yasko said. For example, fewer than 5 percent of people with cancer enroll in clinical oncology trials, she said.

“With the registry, researchers have access to people they wouldn’t have had access to otherwise,” Yasko said. “We consider the registry a success because of the response rate from participants,” which is running at about 15 percent, she said. “Mass mailings, for example, historically get only a 2-5 percent response rate.”

Another measure of success is a comparison with Vanderbilt’s national registry, which was launched prior to Pitt’s and has enrolled about 8,800 participants, she noted.

CTSI recruits subjects in two main ways: At UPMC’s 19 hospitals and outpatient locations — currently 106 of the 400-plus outpatient facilities are locales where people can register, a number that is growing all the time — and at community events such as the Race for the Cure, Yasko said.

Individuals also can sign up at www.researchregistry.pitt.edu/.

“The big thing with the registry is that it’s global. It’s not for any one specific study, it’s not for a specific type of individual, age group, gender, race — it’s for everyone. That’s why I think it’s such a benefit to the researcher, because they can have so many different types of studies with different needs.”

Yasko said that to date only a fraction of the ongoing Pitt and UPMC studies are contained in the registry, something she hopes to improve on.

“There’s a question in the IRB (Institutional Review Board) submission process about whether they want that study to be a part of the registry. It’s left up to the researcher if they want to be listed. I believe the registry will be more successful, not only when we have more participants, but when we also have more studies in the registry. That picks up on both ends,” she said. “We’re trying to get the word out.”

Anecdotal evidence indicates the participant registry has been helpful to researchers in recruiting study subjects, according to Kerri Jackson, Research Participant Registry Office administrator. “We’ve got a lot of positive feedback from coordinators thanking us for our help,” said Jackson, who works with research coordinators to compile study descriptions and eligibility requirements that her staff then share with inquiring participants.

Charles Reynolds, UPMC Endowed Professor in Geriatric Psychiatry and director of the UPMC-Pitt Aging Institute, said, “The recruitment of research subjects is the single most difficult challenge in clinical research, especially for those RO1 (NIH research grant)-funded projects that don’t necessarily have the resources to recruit in vulnerable or underserved populations. That’s why the infrastructure, or the resource, of the CTSI registry is simply invaluable, because it enables researchers to meet recruitment objectives and fulfills the NIH mandate that clinical research include a broadly representative sample.”

Reynolds and colleagues worked with the CTSI Research Participant Registry staff on recruiting subjects for a study titled Prevention of Depression in Older Adults, which focuses on both African Americans and Caucasian Americans. Specifically, the study recruited 240 subjects, about 35 percent of whom are older African Americans.

“Before the CTSI registry existed, our rate was 10-12 percent of African Americans — that’s a threefold increase. The registry allows us to more efficiently recruit and retain participants, not only subjects of color, but also those who may be from vulnerable social and economic circumstances,” Reynolds said.

“The registry also helps fulfill the public health mandate to do clinical research with broad relevance to all citizens and the public health mission to relieve the burden of illness on the nation’s people, particularly where public health need is the greatest,” he added.

“With access to the registry, we were able to recruit older adults at risk for chronic depression, whether it is due to chronic illnesses like arthritis or other conditions such as stroke — in other words to identify some people who have a number of risk factors for chronic depression, many of whom are in difficult-to-reach environments,” Reynolds said.

He added that he is looking forward to using the registry resource to recruit a Pittsburgh cohort for a new national study on prolonged or complicated grief. “Interestingly, all our collaborators in this study are from other CTSI sites around the country,” Reynolds said.

GadiWollstein, associate professor of ophthalmology and director of the Ophthalmic Imaging Research Laboratories, has noticed an uptick in referrals for his longitudinal glaucoma study since the study was listed with the CTSI participant registry.

“The major study I’m working on is an NIH-funded study now in its 11th year. We’re looking for better ways to diagnose glaucoma and to follow patients over time. Glaucoma is hard to diagnose because it is an asymptomatic disease,” Wollstein said. “If we improve our ability to diagnose glaucoma, the study could affect clinical decisions in the future, which is our hope.”

Local subjects contact the clinical coordinator, visit Wollstein’s lab and receive a comprehensive eye examination that includes imaging devices, which the study uses for tracking data over time, Wollstein said.

The study accepts subjects on a rolling basis. Overall, there are more than 1,000 participants nationally in the study, but most of them have been referred from clinicians and already have diagnosed glaucoma, Wollstein said.

“One limitation in our study is when we try to generalize about the general population, it’s difficult because most of our subjects are from clinics. But we’ve been able, with the help of the registry, to increase the pool of volunteers, of healthy subjects,” he said.

“I think we are a nice example of why this registry is a good idea. First, we’ve noticed that the number of potential participants has picked up lately — maybe three-five calls a week, which is far more than usual — from the registry. I think our study has been somewhat under the radar, and having it in the registry helps get the word out,” he said.

“Even more, just two weeks ago, we had a woman from the registry come to us with the designation ‘healthy subject.’ But after a battery of tests we realized she had undiagnosed glaucoma, and finding that out when we did could make a difference in her treatment. So that’s an interesting benefit of this registry,” he noted. “Our experience so far has been very good. It wasn’t a burden, it’s simple to join, so I’m a big supporter of its benefits.”

Rebecca Thurston, assistant professor of psychiatry and epidemiology, also recommended the registry to researchers. “We were recruiting for a small study on the relationship of menopausal hot flashes to cardiovascular function,” Thurston said. “We recruited 40 women, and the CTSI helped. We got some participants because the CTSI had posted our study on the web site, and participants could read about the study. It sped up the recruiting process for us.”

In her other studies Thurston had employed a multi-pronged approach to recruiting subjects, including targeted mailings.

“I think this compared favorably with other recruiting methods. The staff were easy to work with and very accommodating. It is an easy, low budget way for PIs to recruit subjects. I would recommend using the registry.”

For more information on the registry, go to www.researchregistry.pitt.edu/Index.shtml.

—Peter Hart

CTSI recruits registry participants at community events such as the Race for the Cure.