It is commonplace for the leaders of academic medical centers to articulate their mission as a “three-legged stool” comprised of patient care, research and education. But how often are those components all given equal importance when it comes to IT strategy? The reality among academic hospitals and health systems is that the information systems supporting clinical research generally lag far behind those supporting patient care, in terms of funding and interoperability.
But that reality is changing, as new IT tools are developed and enhanced, and even more importantly, as academic medical centers accelerate their efforts to compete for lucrative research dollars. Today, CIOs and other senior executives are developing new strategies to support clinical research with information technology.
One of the best examples of a pioneer in this area is the massive Cleveland Clinic Health System in Ohio (with its nine owned and three affiliate hospitals and 13 clinics). At the Cleveland Clinic, executives and managers, led by CIO C. Martin Harris, M.D., have created an organizational structure to ensure that clinical research gets priority treatment along with patient care and teaching. Harris has directors of those three teams reporting to him.
Out of that structural development work has come an e-research initiative during the past two-and-a-half years. Three capabilities are involved: recruitment, feasibility analysis, and reporting. What's more, Harris says that he and his colleagues have been aiming for a good balance in supporting all three areas with IT.
“We are an academic organization,” Harris emphasizes. “Obviously, patient care is first for us, but the other two legs of the stool for us are research and education. And clinical research plays a role in generating new knowledge, and converting that new knowledge into innovations that we can apply to patient care.”
Robert DiLaura, D.B.A., director of research informatics and computer systems for Cleveland Clinic, observes, “Clinical research is usually the orphan of the healthcare institution; it is underfunded, with little governance. So what happens in many institutions is that the IT organization may be called on to support some of the server, network, and infrastructure of research, even though they don't understand the informatics of it. (They don't understand how to get) the right information, the right way, to drive research and science.”
Fortunately, the Cleveland Clinic organization has a core inpatient and outpatient EMR (from Madison, Wis.-based Epic Systems Corp.), as well as an IT staff dedicated to clinical research support. Cleveland Clinic's clinical research operation also benefits from the evolution of software packages from commercial vendors such as the Fremont, Calif.-based Velos (which Cleveland Clinic and numerous other major academic medical centers are now using, in concert with other tools).
DiLaura says his colleagues went through a thorough vetting process when they chose the Velos solution (which had just been selected when DiLaura arrived at the organization a few years ago). At the time of that selection, there were almost no truly robust commercial solutions in this area, DiLaura notes (indeed, it is a situation that continues to the present, he adds, though Velos appears to be the most robust in the market).
At the moment, DiLaura and his colleagues are pulling demographic patient data from their Epic EMR into Velos, but nothing is integrated yet, though he is examining the potential for using Velos as a kind of integrative platform for the numerous vendor solutions being used at a very micro level in individual clinical trial studies.
National funding spurring informatics
In addition to support from executive management and IT teams, research directors like DiLaura are also benefiting from a major federal funding program that is strongly impacting the path of informatics around clinical research nationwide.
The National Institutes of Health (NIH)'s Clinical and Translational Science Award (CTSA) program, operated via the NIH's National Center for Research Outcomes (NCRO), has enrolled 24 academic medical centers around the United States, and is expected to enroll more over time. The program, established in 2006 (for details, go to http://www.ncrr.nih.gov/clinical_research_resources/clinical_and_translational_science_awards/) is helping to consolidate funding for clinical research nationwide. The NCRO hopes to ultimately enroll 60 institutions in its consortium. Some of the funding coming out of the CTSA program is already spurring greater IT investment and inter-organizational cooperation around clinical research informatics, according to DiLaura and others at CTSA sites.
What's more, all of this is one element in an exciting, if still-emergent, trend: the move towards truly integrating clinical information systems for patient care with those for research. Those involved in using IT to support clinical research are excited by all the potential and looking forward to addressing the challenges.
“One of the big challenges is simply understanding what's needed and when, as these things are still largely in their infancy,” says Brian Athey, Ph.D., associate professor of psychiatry and internal medicine at the University of Michigan in Ann Arbor, and director of the Biomedical Informatics Program at the University of Michigan Medical School.
Athey, who co-chairs the CTSA National Informatics Program Steering Committee, says, “Informatics is a big piece of the CTSA.” And he believes that the CTSA program will help to accelerate clinical research-related informatics nationwide.
“The academic side needs to engage in a productive dialogue with the healthcare IT side,” he emphasizes. “This is particularly true as we move towards the thousand-dollar genome — the availability to tap into genomic information in an economically feasible way in the interest of patient care — becoming a reality, which could happen in the next several years.” In other words, the potential for harnessing IT to fuel both enhancements in clinical research and in direct patient care is quite great, he emphasizes.
“The big challenge is moving these products away from their important niche markets, like cancer, and broadening them out, and properly scaling these out and developing the right links with your departments and programs; you need some IT people involved in doing that,” he stresses. The products Athey refers to are the emerging class of software tools from vendors such as Velos, the Toronto-based Cedara Software (which focuses on off-the-shelf and customized solutions for clinical trial workflow) and others.
Still, just how preliminary the work stands nationwide is borne out by a study published in the Journal of Investigative Medicine in 2006. The study examined numerous detailed aspects of clinical research work, among them the internal review board process, in which clinicians analyze and approve individual research projects that could become trails, and in which such detailed tools as consent form templates — electronic versions of the consent forms patients must sign before being enrolled in clinical trials — are developed.
In surveying the 55 members of the Clinical Research Forum (virtually the entire universe of major academic medical centers with serious research organizations), authors Fran Turisco of Long Beach, Calif.-based First Consulting Group, Diane Keogh, corporate director of research computing at Partners HealthCare system in Boston, and three others found that 44 percent of member organizations were in the process of implementing electronic IRB (internal review board) submissions, 24 percent had already installed such systems; 48 percent had installed adverse event reporting, 72 percent had installed grants management tools, 55 percent had installed protocol design templates, and 48 percent had installed consent form templates.
Qualitatively speaking, says Keogh, “We found that people were at different levels of what they were working on, but there was no single organization that was way ahead of anyone else or complete” in terms of IT facilitation for clinical research. “Data management was all over the place, and access to clinical data to support research was something people were really screaming for but hadn't done very well yet.”
The bottom line, says Keogh — whose job was created three years ago at Partners in order to manage IT support for clinical research at the vast system (with its two large academic centers, six community hospitals, and numerous community health centers — is that “There are not a lot of great vendors out there, and people try to do it on their own, but it's much more complicated than IT for patient care.”
And yet, says Ross Martin, M.D., director of health information convergence for the McLean, Va.-based BearingPoint Inc., the acceleration of clinical research systems will only come to pass when all the stakeholders get involved and push things forward. Martin believes that several elements will have to fall into place in the next several years to move clinical research IT facilitation to the next level.
He foresees large pharmaceutical companies helping to finance investment in IT, with strong ethics safeguards built into clinical research processes through the use of patient identity protections. These features, he says, can be built into information systems, with the help of natural language process standards including the so-called “HL7 GELOO” (Guideline Expression Language, Object-Oriented) standard, which can make queries such as patient eligibility across multiple healthcare organizations, without impinging on patient privacy.
The most exciting aspect of this potential “opening-up,” Martin says, is that if a nationwide information network is ultimately built for academic research, “You wouldn't have to be a Partners HealthCare, Cedars-Sinai, or Mayo Clinic to participate in clinical trials. Ultimately, physicians in community hospitals could come to participate, using economies of scale.”
Duke moves forward
In the meantime, leader organizations are moving forward to integrate their processes and systems. One example of such an institution is Duke University Medical Center in Durham, N.C., another one of the 24 CTSA award recipient organizations. Duke's clinical research operation is a $100 million-per-year program involving over 1,000 people, notes Steve Woody, associate CIO for clinical and translational research at the Duke organization. As at Cleveland Clinic, Duke has put its collective money where its mouth is, and funds a specific chief clinical research information officer position — Woody's.
Woody points out that while clinical research is a money-loser at most academic medical centers (at least with regard to direct return on investment, as opposed to supporting longer-term organizational strategy and enhancing care over time), the Duke Clinical Research Institute of which he is the effective CIO has been breaking even. Strong IT support for research has been one key element in that success, along with skillful management and excellent senior executive leadership from the organization, he says.
Asif Ahmad, Duke's vice president, diagnostic services, and CIO, puts things very plainly. “I think clinical research, in academic medical centers, is as important as the bread and butter of patient care,” he says. “In fact, it's all a part of a continuum. And I'm one of the few CIOs in charge of both types of computing.”
Both executives emphasize that Duke has been working for over a decade to streamline the process of collecting EMR-based data. In the last few years, the organization's major vendor partnership has been with the San Francisco-based McKesson, which collaborates with Duke, Ahmad says, “to co-develop and co-drive their next-generation EMR.”
That work, Ahmad says, ties into the broader aims of the organization's IT development on behalf of research. At present, researchers are pulling data from both the McKesson inpatient EMR and Duke's self-developed ambulatory EMR, into Duke's centralized data warehouse. All the data in that warehouse “gets synthesized into our clinical data repository,” he says, and that repository feeds the Velos solution, which supports the full range of Duke's clinical research projects, including clinical trials.
Duke was, along with Cleveland Clinic, one of two early adopters of the Velos solution among the 24 CTSA awardee organizations; and though Duke and Cleveland Clinic were in the second group of 12 organizations awarded the CTSA grants (in 2007), the use of that vendor has made it a de facto core IT provider to the CTSA group of academic medical centers.
Advice for CIOs: integrate and invest
The ideal IT platform to facilitate clinical trials work, says Claire Verschraegen, M.D., director of the translational therapeutics program at the University of New Mexico Cancer Center in Albuquerque, would provide researchers with quick and easy access to appropriately shareable clinical data. That data could come from across the patient care enterprise — from an organization's core EMR to all the ancillary data, such as laboratory, pharmacy, and diagnostic imaging. It's that kind of data that can also be crucial to assessing the eligibility of a hospital's patients for a clinical trial, enrolling them, and maintaining the stream of clinical data needed as a trial progressed.
She and her colleagues are also customers of Velos, and in addition are able to pull some data from the University of New Mexico Medical Center's core EMR, which is from the Kansas City, Mo.-based Cerner Corporation.
Verschraegen urges hospital and health system CIOs to aggressively pursue the integration of patient care and clinical research systems, and their interoperability, going forward.
Michael Carducci, M.D., agrees with Verschraegen. And he seconds the contentions of Cleveland Clinic's DiLaura that informatics will be key.
“My needs change in terms of who needs what and when,” says Carducci, a professor of oncology and urology at Johns Hopkins in Baltimore, and co-director of the prostate cancer program and clinical therapeutics at the Kimmel Cancer Center there. He says that in some ways, the Hopkins IT infrastructure might be ahead of some organizations, but in other ways, it might be a bit behind.
“But as part of our national collaborative work in prostate cancer and with support from the National Cancer Foundation,” he notes, the Kimmel Cancer Center has “brought Velos in to assist us with the sharing of data across clinical trials, looking at commonalities of disease states within a disease, and sharing that data to get faster turnarounds across a number of institutions.”
CIOs say they're listening. Stephanie Reel, vice president and CIO at the Johns Hopkins Health System, says, “Working with other CIOs to learn from one another will be essential” to moving clinical research forward strategically. She adds that numerous factors are putting pressure on researchers, including the regulatory climate around research, the need for collaboration, the “decreasing or flattening of the NIH budget,” and “the complexity of the pursuit of knowledge,” among other things.
John Glaser, Ph.D., senior vice president and CIO at Partners HealthCare system, says: “Obviously, being competitive and drawing in NIH and other dollars has become more important, and in order to play that game, you've got to put more investment into the game.”
There are many models being pursued for facilitating and optimizing clinical research processes, Glaser says, and no one has yet found any magic-bullet solution to the array of challenges. But, given its high percentage of revenues from academic research, Partners is among the group of academic medical centers that has committed to dedicated IT staffing for clinical research, something that most cite as a key success factor.
In the end, many agree, it will take a lot of work, a lot of collaboration, a fair amount of money, and some time before clinical research reaches the level of IT facilitation that patient care now widely enjoys. Still, pioneering academic medical centers are working hard and fast to produce results. “My great hope is that we will be able to leverage this technology to drive down the cost of conducting clinical trials by enabling e-research capability across large organizations, so that we will be able to reduce the cost of conducting trials, and in that way generate new knowledge more rapidly to benefit patients,” adds Cleveland Clinic's Harris.