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October 12, 2006

Registry aims to find more research subjects

Over the next two years, Pitt will establish a novel clinical research registry, drawing from the millions of patients who annually seek treatment at UPMC facilities throughout the region.

The registry, one of the first of its kind, is one component of Pitt’s $83.5 million National Institutes of Health (NIH) grant to establish the Clinical and Translational Science Institute (CTSI).

Pitt principal investigator Steven Reis, who is associate vice chancellor for clinical research, said, “CTSI will develop a novel methodology that will overcome a major barrier to the performance of research by nearly all clinical and many translations researchers: the inherent difficulty of adequate human subject recruitments.” The clinical research subject registry will be embedded in UPMC’s electronic health record system and implemented at UPMC’s 350 outpatient practice locations and 19 hospitals, he said. Those facilities annually have some 3 million outpatient visits and more than 150,000 inpatient hospitalizations, he noted.

The goal, Reis said, is to get every UPMC network patient’s permission to be contacted for clinical study recruitment.

The process is three-pronged, Reis said. First, upon outpatient registration in any of the UPMC point-of-service offices, patients will be asked to provide written permission to participate in the registry. The system will print an Institutional Review Board-approved consent form and informational material will be provided at the point of contact.

“We think that asking for consent at first contact — rather than an unsolicited mailing, for example, or waiting for responses to posted requests — is crucial,” Reis said. “People are in a health care setting, health is on their minds and they are most susceptible to receiving health-related information.”

Second, after providing consent, all pertinent medical records will be collected and stored in a secure central data repository (CDR). This information will be queried by the CTSI research study database daily to match patients to relevant CTSI studies. “It’s important to note,” Reis said, “that the CDR will be stored on a UPMC server that has privacy protections — firewalls, locked rooms, encryption — that are used by UPMC clinical information systems. These systems afford privacy protection in accordance with all governing laws.”

Third, registry participants will receive a mailing from the CTSI registry office that will provide general information about clinical research to develop a “research-informed patient,” as well as clinical vignettes to demonstrate the benefits of research participation, general wellness information, information relevant to a patient’s medical profile and a list of relevant research studies.

The customized mailings will be followed up by phone contact, which will provide participants with contact information of study investigators and forms that participants can send to the registry office granting permission to research investigators to initiate contact with them.

“The way it is set up, you agree to be contacted about potential research studies, so you’re not in a study and not committed to a study,” Reis said. “You will be sent out general health information that is relevant to that person’s health issues, so people have a better understating of how clinical research has had an impact on their own health. We don’t have polio because of the polio vaccine, for example, which was developed through clinical research.

“There really are two levels to this,” Reis continued. “The first level is that through information technology, we would be able to search through a person’s records in a secure environment. Using an IT system and an ‘honest broker,’ we would preferentially sort out studies that may be relevant to certain conditions the person has and send out information. If the person is interested, we would forward more information about what is entailed in a study, before we would even hook them up with an investigator.”

(In the human research setting, the honest broker acts as a neutral mediator, serving as a disinterested intermediary between a researcher and a study participant to ensure that the researcher is not recording any personally identifiable data about the individual.)

“For the next level,” Reis said, “we envision that a PCP (primary care physician) can type in a patient’s identification number, and the computer will sort through the medical record and identify potential studies, or that the PCP can put in a specific request, ‘I’m interested in studies about this particular condition,’ for example. The keys are that this will done through an IT system and it would be done through an honest broker, so that privacy is maintained.”

—Peter Hart

Filed under: Feature,Volume 39 Issue 4

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