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November 6, 2008

Volunteer registry for clinical trials debuts

Coming soon to a UPMC outpatient facility near you: A system that enables people to sign up as potential participants in clinical research studies.

Two years in preparation, the Research Participant Registry, one of the first of its kind, is one 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 grant.

Last month CTSI, in partnership with UPMC, piloted the registry at two UPMC outpatient sites — a specialty care clinic and a general internal medicine practice.

In just a few weeks, more than 250 patients at the two sites signed up, said Steven Reis, Pitt associate vice chancellor for clinical research.

“We take that as a great sign,” Reis said. “One of our purposes in the CTSI is to improve health through research. In order to achieve that we need to promote opportunities for people to participate in research, as well as to provide education to people so that they understand what research is, how they may benefit from research, how to participate in research and what research is available. The registry addresses all of these, with the ultimate goal to develop a research-informed community.”

The registry will expand clinical trial recruitment to a large outpatient population in a health care setting, where health is on people’s minds and they likely are most susceptible to receiving health-related information, Reis said, as opposed to unsolicited mailings, cold calls, costly advertising and more haphazard matching of participants to clinical studies that is typical of human subject recruitment.

Reis stressed that while CTSI is a Pitt institute, the registry could not have been established without the collaboration of UPMC, with its 400-plus outpatient offices and hospitals handling more than 4 million outpatient visits per year. Pitt and UPMC agreed that the clinical registry would be beneficial for both patients and health care providers, as well as for researchers.

“We thought it was good way to reach a large number of diverse UPMC patients throughout the region. The potential scope of the registry is very large,” Reis said. “When we analyzed the workflow, informally, we realized that most if not all of the UPMC offices use the same electronic patient registration system. When the patient comes in to a see a health care provider, someone registers that person, takes down demographic information and insurance information, and puts it into one giant database. Since that was already available, we built the research registry around this electronic registration system.”

Outpatient registrars are being trained to ask patients at the point of entry whether they are interested in participating by signing an Institutional Review Board-approved consent form, which can be printed on the spot.

“If a person agrees and signs the informed consent, several things happen,” Reis said. “First, we tag them in the UPMC registration system, so we know that they agreed to participate and we won’t be asking them again every time they see a physician. We’re trying to put the least amount of burden on the participant. The consent form does not commit the patient to any study,” Reis noted.

Those who sign up initially receive a letter that explains what the registry is all about, he said. Contained in the initial packet also is a preference flyer, where registrants can mail back information about how they wish to be contacted — phone, mail or email — and whether there are specific medical conditions that are of interest to them.

The initial consent permits the registry system to access a patient’s electronic health record and match the information with a list of inclusion and exclusion criteria for specific ongoing clinical studies, as well as match the patient’s preferences for information about particular conditions.

This is done in a central office with a secure data repository to preserve confidentiality, Reis said.

“One critical point in this is the efforts we are making to preserve confidentiality,” he said. ”We have one central research registry office. Names are not being sent to investigators. The interactions will be with this office, and the names will not be forwarded nor will the medical records be forwarded without permission from the participant, so in addition to signing the initial consent, they would have to sign another consent form to provide that permission.”

Next, Reis said, registrants will receive a mailing typically on about five-seven clinical research trials with some general background on each.

“If they’re interested in participating in a study, they will contact us,” he said. “Right now it’s set up as a phone contact, but eventually we’re going to set it up to allow online contact. We will talk with them, screen them through the central office, again to preserve confidentiality, and if the patient, who already is a research registrant, agrees, then we will link them with an investigator.”

The studies mailed to the registrants are not always triggered by a specific medical condition in a registrant’s medical record. “There may be other interesting studies as well, to give people opportunities,” Reis said. “People may not be interested in the five-seven studies we’re giving them, but if we engage them in the process and they understand that the studies may or may not be beneficial to them directly, or if they have an altruistic reason to participate in research, we’re hoping they’ll contact us and look for additional studies. We always need healthy volunteers for control groups.”

There are more than 6,000 ongoing, IRB-approved clinical research studies at the University currently, so the scope of research is very broad, Reis noted. “There are opportunities for healthy people, for people with many different medical problems and for people interested in different types of therapies for their medical issues,” he said.

When a registrant calls the central office, the individual reaches a person 24 hours a day, a screener who will ask additional questions to determine eligibility, Reis noted.

“Few people participate in clinical research. Data show, for instance, that fewer than 5 percent of people with cancer participate in clinical studies. There are many reasons why people don’t participate,” Reis said.

“One reason is because opportunities may not be presented to them, they may not even know about trials. Maybe the health care provider is not in an academic environment, for instance. Another reason is that maybe people do not understand the clinical research process, or don’t understand the potential benefits of participating in clinical research.”

Or, people know about a particular study but may not know the logistics of how to access the study: Whom do you call? How do you actually get involved in the study? he said.

“The registry hits all of those: We’ll help increase awareness about clinical research, we will help by presenting potential studies to registrants and we’ll help with the logistics through this intake system,” Reis said. “Along the way, by the process we’ve designed, we will provide information about health issues in general in the form of quarterly mailings, all in a single point of service.”

While the roll-out of the pilot program has been small to begin with — with the two offices already online and two others to be activated within a few weeks — once the bugs in the system have been solved, a rapid expansion into other UPMC outpatients sites is expected, Reis said. “Our goal is to provide access to the registry in every UPMC outpatient site in the next three years,” he said.

“What I want people to think is that we’re doing this because this is a partnership between us and the larger community.

“Our goal is not solely to increase the number of people in research studies; our goal is to improve health through research. One reason we can do this is that we are not promoting a specific study. We have a broad mission. We are a University office designed to support research to improve health. It’s a University office that provides resources not only to the researcher but also to the general public.”

A companion initiative to the research registry is an effort to enroll those who are not UPMC patients, said Laurel Yasko, administrative director of operations at CTSI, who has helped set up the system.

“We’re setting up what we call our community registry, a general registry. We won’t have the individual’s medical record information, but you can sign up to get general information about research,” Yasko said. “For that side of the registry, we’ll have it at our community outreach sites, where we do health screenings and provide health information, and on our web site. You fill out your name and address and say ‘I’m interested in general information or information on cancer studies,’ or whatever your preference is. You don’t sign a consent form; you’re saying ‘I’m interested,’ and for that we don’t need the medical record. We’ll send them information about what they request. That may mean they have a certain condition or just that they’re interested in clinical research.”

For more information on the Research Participant Registry, call 1-866/438-8230 or go to the web site:

—Peter Hart

Filed under: Feature,Volume 41 Issue 6

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