New partnership hopes to build methodology to use medical records to facilitate clinical research.

By Allison Proffitt

March 23, 2011 | The Partnership to Advance Clinical electronic Research or PACeR (www.pacerhealth.org) was created to “convene the users and the collectors of the data to understand how we can safely reuse electronic medical record data to facilitate clinical research,” explains David Krusch, chief medical information officer at the University of Rochester Medical Center and chair of the PACeR leadership committee.

Initiated by Pfizer and Quintiles, PACeR’s leadership committee consists of pharmaceutical companies Merck and Johnson and Johnson, hospitals St. Luke’s Roosevelt and Stoneybrook University Medical Center, and IT companies. PACeR recent announced that Oracle has signed on as the first IT company in the partnership.

The overarching goal of PACeR, Krusch says, “is to design a methodology by which we can reuse electronic health record data for the purpose of facilitating clinical research” which includes investigating protocol design, recruitment and identification of candidates for studies, and ultimately the use of the data itself for the conduct of the study.

“We had a data discovery process by where we went to each individual major institution and we analyzed their EMR data to see how well it could address the questions that would be asked of it,” explains Krusch.

The data mining exercise approached six member hospitals, taking six clinical protocols commonly used by the pharma industry and setting up hypothetical trials at each hospital using the protocols seeking to gather patient demographic information, clinical conditions, test history, and comorbid conditions. Not all protocols were applicable for all six hospitals (for example, Roswell Park is a cancer hospital, so only the cancer protocols were appropriate), but the results were still surprising.

“We found that the specialty hospitals such as Roswell Park were able to populate the protocol with about 80% of the population that would be needed,” said Terri Straub, a PACeR Consultant. “However when we went to other hospitals that were partners, depending on the hospital and the protocol, they were only able to populate anywhere from 30% to 60% of protocols, meaning a tremendous amount of extra work [would need] to be done to get patients enrolled in any type of clinical trial.”

One of the problems, Straub says, is that the data is at the hospital, it’s just hard to find. Straub lists several databases that may exist in a hospital—the American Heart Association data, the American College of Surgeons data on infection prevention—that wouldn’t be queried when a sponsor was trying to set up a trial. “There are these disparate databases that hospitals and doctors’ offices pay for, they submit their data, but that data is not part of the ecosystem of the EMR.”

Oracle’s role in this challenge would be to find solutions and interfaces to gather data from different data sources in the hospital. “We’re working with Oracle and the hospitals to say, ‘Is there a better interface—an overlay—that we could put on top of all of your databases to poll data in a more standardized way?’” Straub explains, and says that PACeR is also working closely with HL7 and CDISC to agree on the common data that should be captured.

Straub believes PACeR is in a unique position to address this question, because of the relationship it enables between pharma and hospitals. The Healthcare Association of New York State (HANYS) manages PACeR and serves as the crucial “neutral party” to connect hospitals and the pharma industry, she says. “The pharma industry is now looking toward HANYS saying, We want to do this right. This is about the patients; this is about a business model that needs to be developed to be sustainable.” Hospitals hope to answer questions such as, How does a hospital better position itself for research? How do we engage the physician community to be part of this? How can we streamline the whole [IRB and privacy] process?

In New York, Straub says that HANYS hospitals do hope to refine their processes and in turn gain some advantage as a clinical trials site. “If hospitals adopt the PACeR protocols and they become a PACeR hospital, can we expedite the [clinical trials] process?” she asks. But Krusch emphasizes, “We’re not restricting ourselves to New York. It’s a great place to start because we have a cohesive group to hold us together, but when we develop this model [it] should be agnostic of geography.”

The pharma partners have contributed funds to support PACeR and the data mining exercises and the hospitals participate through in kind donations. HANYS is supported by the pharma contributions and serves as the manager and administrative arm of PACeR. In addition to the large-scale exercises, through PACeR pharma can launch smaller demonstration projects to investigate very specific topics. For instance, Straub says, Johnson & Johnson is interested in looking at processes around orthopedic devices and PACeR is in the process of recruiting hospitals and orthopedic surgeons.

Phase two of the initiative should start in March with the publishing of a white paper of PACeR’s Phase one findings. Krusch says PACeR will then put together a business model to define PACeR as an entity so that it can facilitate the connection between pharma and device [companies] and other research initiatives with the PACeR participants.

A good place to start? “The delays in recruiting patients to a clinical trial are far too long, and not only are they far too long, but when we get the patients in the trial we find out that ultimately 50% of them are not eligible to being in the trial anyway,” says Straub. “Hospitals are putting a lot of time and effort into capturing data that’s not being utilized in a more systematic way and it doesn’t align itself with the other activity in the hospital.”